John SchroyerDecember 5, 2022
Epidiolex remains the only cannabis-derived medicine approved by the U.S. FDA.
Jazz Pharmaceuticals Archives - Green Market Report
John SchroyerDecember 5, 2022
Dave HodesSeptember 6, 2022
legitimate, medical psychedelics is gaining ground as an acceptable mental health therapy in clinical trials.
StaffJune 28, 2022
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced top-line results from the Phase 3 RELEASE MSS1 trial (NCT04657666) evaluating nabiximols oromucosal spray (JZP378, or Sativex , ex-U.S.) on clinical measures of spasticity in individuals with multiple sclerosis (MS). The RELEASE MSS1 trial did not meet the primary endpoint of change in Lower Limb Muscle Tone-6 (LLMT-6) between baseline and Day 21, as measured by the Modified Ashworth Scale (MAS).
“We remain committed to the nabiximols program and are actively assessing the RELEASE MSS1 trial results, which will be presented at a future medical meeting. We look forward to additional data from two other ongoing trials that have the potential to support a U.S. FDA New Drug Application submission,” said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development at Jazz Pharmaceuticals. “I would like to extend a heartfelt thank you to all those who supported and made this study possible, including the patients who were enrolled, their families, our investigators, staff, and all of the dedicated Jazz employees.”
The Sativex or nabiximols oromucosal spray is a complex botanical mixture formulated from extracts of the cannabis sativa plant and contains the cannabinoids delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), as well as other cannabinoid and non-cannabinoid components. Nabiximols oromucosal spray (known as Sativex ex-U.S. and first approved in the U.K. in 2010) has been approved in 29 countries for the treatment of adult patients with moderate to severe spasticity due to MS who have not responded adequately to other anti-spasticity medication based on previously completed clinical trials.
Multiple sclerosis (MS) spasticity is one of the most common motor symptoms associated with MS. MS spasticity often manifests as involuntary muscle stiffness and/or spasms, occurring in up to 84% of individuals with MS, and approximately one-third of individuals with MS still live with uncontrolled spasticity symptoms. However, MS spasticity can also lead to pain, sexual dysfunction, dysarthria, fatigue, depression and anxiety, mobility impairment, bladder and bowel dysfunction, and sleep disturbances. Less than half of individuals with MS receiving treatment for spasticity are satisfied with the current treatment regimens and 41% of physicians are dissatisfied with current treatment regimens.
Despite the disappointment of this study, there are two additional, ongoing Phase 3 trials for the treatment of MS:
- RELEASE MSS3: A Phase 3 multicenter, double-blind, placebo-controlled trial evaluating the efficacy of nabiximols oromucosal spray, compared to placebo, when added to standard of care, for the improvement of muscle spasms associated with MS over a 12-week treatment period. The estimated enrollment is 446 participants.
- RELEASE MSS5: A Phase 3 multicenter, randomized, double-blind, placebo-controlled, 2-treatment, 2-period, crossover trial evaluating the effect of multiple doses of nabiximols oromucosal spray compared to placebo on a clinical measure of velocity-dependent muscle tone in the lower limbs (Lower Limb Muscle Tone-6 [LLMT-6]) in participants with MS over a 3-week treatment period. The estimated enrollment is 190 participants.
StaffMay 5, 2022Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced financial results for the first quarter of 2022, raised 2022 financial guidance, and provided business updates.
“We’re pleased to raise our top- and bottom-line guidance, driven by our continued execution and significant progress across commercial and R&D in the first quarter, which positions us well for the rest of the year and to achieve Vision 2025,” said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. “Our recent launches of Xywav, in both narcolepsy and idiopathic hypersomnia (IH), and Rylaze in acute lymphoblastic leukemia (ALL), continue to generate increased prescriber and patient adoption, and demonstrate our ability to deliver innovative new medicines to improve the lives of patients and their families. On the corporate development front, our three recent transactions are aligned with our broader strategy, allowing us to focus on our highest priorities, enhance our pipeline in areas of key interest in neuroscience and oncology and drive long-term shareholder value.”
GAAP net income in 1Q22 was $1.6 million, or $0.03 per diluted share, compared to $121.8 million, or $2.09 per diluted share, for 1Q22. Non-GAAP adjusted net income in 1Q22 was $261.9 million, or $3.73 per diluted share, compared to $228.8 million, or $3.92 per diluted share, for 1Q22.
Epidiolex Results
Jazz reported that its Epidiolex/Epidyolex net product sales increased 6% to $157.9 million in the first quarter of 2022 compared to the same period in 2021, on a proforma basis. Epidiolex/Epidyolex net product sales in the fourth quarter were favorably impacted by approximately $18 million, due to a temporary increase in specialty pharmacy inventory levels at the end of 2021. The majority of this increase reversed in 1Q22, reducing 1Q22 revenues.
“Excluding this impact, we saw double-digit percentage revenue growth in 1Q22 compared to 1Q21, and sequential growth in underlying demand, despite challenges posed by the Omicron variant.”
Jazz said that Epidyolex is now commercially available and fully reimbursed in four of the five key European markets: United Kingdom, Germany, Italy and Spain, with an anticipated launch in France in 2022. The company said it has made significant progress on its European rollout with launches in Spain, Italy and Switzerland in 3Q21 and Ireland and Norway in 1Q22.
Jazz said it expects to initiate a Phase 3 pivotal trial of Epidiolex for Epilepsy with Myoclonic-Atonic Seizures (EMAS), the fourth target indication for Epidiolex, in 1H22. The company continues to strengthen the durability of Epidiolex. Patent US 11,207,292 is Orange Book listed and extends through 2039. This patent covers the composition of the botanically derived cannabidiol (CBD) preparation used in Epidiolex and the treatment of indicated disorders using that CBD preparation.
StaffNovember 10, 2021
After the market closed on Tuesday, Jazz Pharmaceuticals plc (Nasdaq: JAZZ) released its financial results for the third quarter of 2021 and updated financial guidance for 2021. Total revenues for Jazz increased 39% to $838.1 million versus last year’s third quarter. This beat the Yahoo Finance average analyst estimate for revenue of $834 million. The GAAP net loss for the quarter was ($52.8 million), or ($0.86) per diluted share, compared to $148.2 million, or $2.64 per diluted share, for the same time period in 2020.
Non-GAAP adjusted net income for 3Q21 was $261.4 million, or $4.20 per diluted share, compared to $242.1 million, or $4.31 per diluted share, for 3Q20. This also beat the estimate for earnings of $3.37. The stock was moving higher by almost 2% to lately sell at $134. The average price target is $205.
Outlook
Jazz is also raising its full-year earnings guidance, resulting in a reduced GAAP net loss and increased non-GAAP adjusted net income (ANI) on an absolute and per share basis. The revenue guidance given in August was for a range of total revenues between $3,020 to $3,180 and that was changed to a range of $3,020 to $3,100.
The updated non-GAAP ANI range exceeds the upper end of the prior range. The company is also reducing both SG&A and R&D expense guidance on a GAAP and non-GAAP adjusted basis, reflecting progress within its transformation initiatives, improved financial discipline, and strategic capital allocation. The company is narrowing its net sales guidance range for neuroscience and oncology, with a reduced mid-point for oncology net sales guidance which reflects the ongoing impacts of COVID-19 on our legacy products and the Rylaze competitive landscape at launch in 3Q21, resulting in a reduced mid-point for total revenues guidance.
“Last year, we set the ambitious corporate objective of completing five key commercial launches through 2020 and 2021. With the launch of Xywav for idiopathic hypersomnia earlier this month, we have now accomplished this goal, demonstrating our significant execution capabilities and commitment to bring important new medicines forward for patients,” said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. “The successful integration of GW underscores our ability to deliver on transformative M&A to grow our business. While there’s more work to be done, I’m confident we have the right strategy, teams, and capabilities in place to realize the blockbuster potential of Epidiolex and to discover, develop and launch additional novel, innovative medicines leveraging cannabinoid science. Our commercial execution, productive R&D engine and culture of commitment to patients and their families provide a strong foundation for significant and sustained growth.”
Epidiolex Update
Jazz reported that Epidiolex/Epidyolex net product sales were $160.4 million in the quarter, an increase of 21% compared to the same period of 2020 on a pro-forma basis, despite short-term COVID-19 pressure. Recent market research indicates approximately 40% of prescribers are moving Epidiolex up in their treatment algorithm. The company has made significant progress on its European rollout with launches in Spain, Italy and Switzerland in 3Q21. Epidyolex is now commercially available and fully reimbursed in four of the five key European markets: United Kingdom, Germany, Italy and Spain, with an anticipated launch in France in 2022.
The company said it expects to initiate a Phase 3 pivotal trial of Epidiolex for Epilepsy with Myoclonic-Atonic Seizures (EMAS), the fourth target indication for Epidiolex, in 1H22. Jazz also said it continues to strengthen the durability of Epidiolex, and expects a composition of matter-like patent, extending through 2039, to be issued later this year.
Renée Galá, executive vice president and chief financial officer, added, “This is an exciting time of transformation for Jazz, underpinned by operational execution, financial discipline and strategic capital allocation across our business. We continue to deliver on our business and financial targets which has enabled us to rapidly reduce our net leverage ratio to 4.4 times in just five months following the close of the GW transaction. We have also delivered on revenue growth and diversification. Recently launched or acquired products now make up over 50% of net product sales, and we remain on track to meet our goal of at least 65% in 2022. In addition, our prior investments in corporate development are translating into near-term catalysts as we advance JZP385, JZP150 and Zepzelca into important new clinical trials. We will continue to prioritize disciplined capital allocation to assets and activities that drive growth and value, while remaining focused on achieving our net leverage ratio target of less than 3.5 times by the end of next year.”
Debra BorchardtAugust 4, 2021
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.”
Debra BorchardtJune 17, 2021
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) raised its full-year 2021 financial guidance based on the acquisition of GW Pharmaceuticals, which was bought on May 5, 2021. The May 4, 2021 guidance for revenue was in the range of $2.5 – $2.7 billion. That has been increased as of June 17, 2021, to a range of $3.0 to $3.1 billion. Jazz said it expects to generate 65% of 2022 revenues from products that have been launched or acquired since 2019. The 2021 guidance for a GAAP net loss is in the range of $290 – $125 million.
“We expect 2021 to be another exciting, productive, and transformational year for Jazz and are pleased to update our guidance to include the addition of GW. Our guidance reflects strong execution across our commercial portfolio, continued investment in both our ongoing and planned launches, and strategic investments in R&D to advance therapies to patients in critical need of new treatment options. These investments will support the recent successful launches of both Xywav and Zepzelca, the ongoing growth of Epidiolex, the anticipated launches of JZP458 for ALL or LBL and Xywav in idiopathic hypersomnia, and the rolling launch of Epidyolex in Europe. As part of our continued R&D efforts we also look forward to advancing our PTSD and essential tremor programs, the nabiximols clinical trial program to support a U.S. regulatory approval, and our new cannabinoid research platform,” said Renée Galá, the chief financial officer of Jazz Pharmaceuticals. “We believe Epidiolex has near-term blockbuster potential and expect the addition of Epidiolex and the GW pipeline to deliver double-digit revenue growth, accelerated revenue diversification and substantial shareholder value. With the addition of GW, we are excited to transform the lives of even more patients and their families.”
Still, Jazz noted that the acquisition will be dilutive to both GAAP and non-GAAP adjusted net income per diluted share in 2021. The company said in a statement that on a GAAP basis, this is primarily due to an increase in the amortization of acquisition-related intangible asset and transaction and integration expenses, the amortization of inventory fair value step-up, increased interest expense, and the increase in the number of outstanding shares relating to the GW acquisition. However, Jazz also said that the GW acquisition is expected to be non-GAAP adjusted EPS accretive in the first full calendar year of combined operations and substantially accretive thereafter.
The guidance is as follows:
| GAAP net loss per diluted share | ($4.70) – ($2.00) |
| Non-GAAP adjusted net income per diluted share | $13.40 – $14.70 |
Jazz does expect strong cash flows, which will allow for rapid deleveraging, targeting less than 3.5x net leverage by the end of 2022.
StaffMay 5, 2021Jazz Pharmaceuticals plc (Nasdaq: JAZZ) closed on its acquisition of GW Pharmaceuticals and announced financial results for the first quarter of 2021 and affirmed financial guidance for 2021. On February 3, 2021, the company said it planned to buy GW Pharmaceuticals for $220.00 per American Depositary Share for a total value of approximately $7.2 billion, or $6.7 billion net of GW cash.
“The addition of GW further diversifies our commercial portfolio and innovative pipeline with therapies that are complementary to our existing business, including Epidiolex, a high-growth commercial product with near-term blockbuster potential,” said Bruce Cozadd, chairman, and chief executive officer of Jazz Pharmaceuticals. “We are fortunate to be combining two companies that share a passion for, and track record of, developing differentiated therapies that advance science and the care of patients with often-overlooked diseases.”
The acquisition is expected to provide accelerated double-digit top-line revenue growth and to be accretive in the first full calendar year of combined operations, and substantially accretive thereafter. Jazz’s strong cash flow profile provides the capability to rapidly deleverage to a target net leverage of less than 3.5x by the end of 2022. Chris Tovey, chief operating officer (COO) of GW since 2012, will join Jazz’s executive management as executive vice president, chief operating officer, and managing director Europe & International, reporting to Dan Swisher, president.
Earnings
Total revenues increased 14% in the first quarter of 2021 to $607 million compared to the same period in 2020 which was $534 million. This was on target the average analyst estimates according to Yahoo Finance but missed the Zacks Consensus Estimate of $613.0 million. GAAP net income for the first quarter of 2021 was $121.8 million, or $2.09 per diluted share, compared to a GAAP net loss of $157.8 million, or $2.82 per diluted share, for the first quarter of 2020. Non-GAAP adjusted net income for the first quarter of 2021 was $228.8 million, or $3.92 per diluted share, compared to $25.8 million, or $0.45 per diluted share, for the first quarter of 2020.
“Demand for Xywav is strong, as both patients and physicians embrace the health benefits associated with reducing daily sodium intake. We also continue to see robust uptake of Zepzelca among both platinum-resistant and platinum-sensitive small cell lung cancer patients, consistent with the positive feedback we’ve received on its profile,” said Cozadd. “We are on track to deliver significant revenue growth and diversification in 2022, are poised for two additional product launches this year.”
Robert Iannone, M.D., M.S.C.E., executive vice president, research and development, and chief medical officer, added, “Across our R&D organization, we’ve continued our track record of strong execution. We presented positive Xywav data in idiopathic hypersomnia (IH) at the American Academy of Neurology Annual Meeting. We are also pleased to have announced that FDA granted priority review of Xywav in IH with a PDUFA goal date set for August 12, 2021, bringing us another step closer to delivering this important treatment to patients with IH, for whom there is currently no FDA-approved therapy. Further, our JZP458 program remains on track with a potential approval in mid-2021. I’m proud that our continued execution enables us to bring life-changing medicines to often overlooked patient groups with significant unmet need.”
The average price target for Jazz is $203 and the stock is currently selling at $166.
Debra BorchardtFebruary 3, 2021
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is buying GW Pharmaceuticals plc (Nasdaq: GWPH) in a deal valued at $7.2 billion or $6.7 billion net of GW cash. Jazz will acquire GW for $220.00 per American Depositary Share (ADS), in the form of $200.00 in cash and $20.00 in Jazz ordinary shares. The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in the second quarter of 2021.
The stock is jumping over 46% in early trading to lately sell at $213.
“Jazz is proud of our leadership position in sleep medicines and rapidly growing oncology business. We are excited to add GW’s industry-leading cannabinoid platform, innovative pipeline, and products, which will strengthen and broaden our neuroscience portfolio, further diversify our revenue and drive sustainable, long-term value creation opportunities,” said Bruce Cozadd, chairman, and CEO of Jazz Pharmaceuticals. “We are joining two teams that share a passion for, and track record of, developing differentiated therapies that advance science and transform the lives of patients. This will help facilitate successful integration and bring added capabilities to Jazz. Given the strength of our balance sheet and the meaningful financial drivers of the transaction, we are confident in the value we can deliver to both companies’ shareholders and patients. We look forward to welcoming the GW team to Jazz to build an even stronger company.”
Jazz is a global biopharmaceutical company dedicated to developing and commercializing life-changing medicines that transform the lives of patients with serious diseases — often with limited or no options. The company’s focus is in neuroscience, including sleep and movement disorders, and in oncology, including hematologic malignancies and solid tumors.
GW Pharm is well known to the cannabis community. It is a global leader in discovering, developing, manufacturing, and commercializing novel, regulatory approved therapeutics from its proprietary cannabinoid product platform to address a broad range of diseases. The company’s lead product, Epidiolex (cannabidiol) oral solution, is approved in patients one-year and older for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS), Dravet Syndrome, and Tuberous Sclerosis Complex (TSC), all of which are rare diseases characterized by severe early-onset epilepsy Epidiolex was the first plant-derived cannabinoid medicine ever approved by the U.S. Food and Drug Administration (FDA). This product has also been approved, under the tradename Epidyolex, by the European Medicines Agency (EMA) in patients two years of age and older for the adjunctive treatment of seizures associated with LGS and Dravet syndrome in conjunction with clobazam and is under EMA review for the treatment of seizures associated with TSC. In addition to the approved indications for Epidiolex, there are considerable opportunities to pursue other indications within the epilepsy field, including other treatment-resistant epilepsies where significant unmet needs of patients exist.
Beyond Epidiolex, GW has a scientific platform and deep innovative pipeline of cannabinoid product candidates, as well as highly specialized manufacturing expertise, developed over two decades of pioneering and building leadership in cannabinoid science. This pipeline includes nabiximols, for which the company is in Phase 3 trials to seek FDA approval for treatment of spasticity associated with multiple sclerosis and spinal cord injury, as well as earlier-stage cannabinoid product candidates for autism and schizophrenia.
“Over the last two decades, GW has built an unparalleled global leadership position in cannabinoid science, including the successful launch of Epidiolex, a breakthrough product within the field of epilepsy, and a diverse and robust neuroscience pipeline. We believe that Jazz is an ideal growth partner that is committed to supporting our commercial efforts, as well as ongoing clinical and research programs,” said Justin Gover, CEO of GW Pharmaceuticals. “We have a shared vision of developing and commercializing innovative medicines that address significant unmet needs in neuroscience and an approach of putting patients first. Together, we will have an opportunity to reach and impact more patients through a broader portfolio of neuroscience-focused therapies than ever before.”
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