Jazz Pharmaceuticals Announces 3rd Quarter 2022 Financial Results and Raises Total Revenue Guidance Mid-point.

DUBLIN: Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the third quarter of 2022, and raised the mid-point of 2022 total revenue guidance.

"Our execution across our business continues to chart a clear path to delivering on Vision 2025. We have further strengthened our operations, and our business is performing well as we've diversified our revenue streams and rapidly deleveraged, while delivering meaningful top- and bottom-line growth. We have also achieved another important milestone -- exiting October 2022, there are now more narcolepsy patients taking Xywav(r) than Xyrem(r)," said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. "We're pleased with the performance across our key products: compelling Xywav adoption across both narcolepsy and idiopathic hypersomnia (IH) continues to drive oxybate durability, Epidiolex(r) delivered significant year-over-year growth driven by underlying demand, strong demand for Rylaze(r) underscores the substantial unmet need and Zepzelca(r) remains the treatment of choice in second-line small cell lung cancer (SCLC). Based on this performance, we are raising the mid-point for our 2022 full year revenue guidance and continue to focus on long-term sustainable growth."

"We have prioritized and invested in key programs leading to significant progress across our pipeline. I'm pleased to announce we have enrolled the first patients in both our Phase 1 clinical trial of JZP815, a pan-RAF inhibitor, and our Phase 3 trial of Epidyolex(r) in Japan," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "Upon close of the transaction, we are excited to further expand our pipeline with zanidatamab, a novel HER2-targeted bispecific antibody in late-stage trials with the potential to transform the current standard of care in multiple HER2-expressing cancers, and also through the initiation of a Phase 2 clinical trial evaluating suvecaltamide (JZP385) in Parkinson's disease tremor. We also continue to advance the JZP441 orexin-2 receptor agonist program. Together, this pipeline progress underscores an exciting time for R&D at Jazz as we look to deliver innovative therapies for patients in critical need."

Key Highlights

Business and Execution

Compelling adoption of Xywav in narcolepsy and IH driving oxybate durability.

Achieved a significant milestone exiting October 2022, with more narcolepsy patients taking Xywav than Xyrem.

Expect Epidyolex to be launched in all five key European markets by year end, following recent successful completion of pricing and reimbursement in France.

Expanded oncology portfolio with zanidatamab, a novel, late-stage asset, currently being studied in two pivotal trials: first-line HER2-positive gastroesophageal adenocarcinoma (GEA) and second-line HER-2 positive biliary tract cancer (BTC)1.

Enrolled the first patient in a Phase 1 clinical trial evaluating JZP815 in patients with advanced or metastatic solid tumors with MAPK pathway alterations.

Enrolled the first patient in a Phase 3 pivotal trial of Epidyolex in Japan for Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS) and Tuberous Sclerosis Complex (TSC).

Initiated a Phase 3 pivotal trial of Epidiolex for Epilepsy with Myoclonic-Atonic Seizures (EMAS), the fourth target indication for Epidiolex.

Initiated a Phase 2 trial for suvecaltamide (JZP385) in Parkinson's disease tremor.

Financial

Raising the mid-point of 2022 total revenue guidance to $3.65 billion driven by increases in the guidance mid-point for both our Neuroscience and Oncology therapeutic areas.

Growing and durable commercial franchises drove 3Q22 total revenues of $940.7 million; 12% increase compared to the same period in 2021.

Continued progress in demonstrating operational excellence and ability to leverage our selling, general and administrative (SG&A) expenses, with SG&A expense as a percentage of sales decreasing in 3Q22 and year-to-date, relative to the same periods in 2021.

Strong operating cash flow year-to-date of $930.0 million, with a cash balance of $899.4 million as of September 30, 2022, and net leverage ratio of 2.9x2.

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1. Pending transaction close.

2. On a pro forma non-GAAP adjusted basis. Non-GAAP net leverage ratio is a non-GAAP financial measure. For further information, see "Non-GAAP Financial Measures."

   Business Updates

   Key Commercial Products

   Oxybate (Xywav and Xyrem):

   Net product sales for the combined oxybate business increased 11% to $512.0 million in 3Q22 compared to the same period in 2021.

   Average active oxybate patients on therapy was approximately 17,600 in 3Q22, an increase of approximately 10% compared to the same period in 2021.

   Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:

   Xywav net product sales increased 67% to $255.9 million in 3Q22 compared to the same period in 2021.

   There were approximately 9,500 active Xywav patients exiting 3Q22.

   Xywav has broad patent protection to 2033.

   Xywav for Narcolepsy:

   There were approximately 8,050 narcolepsy patients taking Xywav exiting 3Q22.

   Achieved another significant milestone exiting October 2022, with more narcolepsy patients taking Xywav than Xyrem.

   The benefits of lowering sodium intake continue to resonate with patients and prescribers. In June 2021, the U.S. Food and Drug Administration (FDA) recognized seven years of Orphan Drug Exclusivity (ODE), through July 2027, for Xywav and published its summary of clinical superiority findings.

   Xywav for Idiopathic Hypersomnia (IH):

   Compelling growth with approximately 1,450 IH patients taking Xywav exiting 3Q22.

   The Company has achieved its goal of obtaining similar payer coverage to narcolepsy, with coverage now at approximately 90% of commercial lives for IH.

   The Company launched Xywav, the first and only treatment approved by FDA for IH, in November 2021. Initial launch efforts have focused on the approximately 37,000 currently diagnosed patients in the U.S. who are actively seeking healthcare. Healthcare providers are excited to have a treatment option with positive and compelling clinical trial results that addresses IH and not just its symptoms.

   FDA recognized ODE for IH in January 2022, extending regulatory exclusivity to August 2028.

   Xyrem (sodium oxybate) oral solution:

   Xyrem net product sales decreased 17% to $256.0 million in 3Q22 compared to the same period in 2021, reflecting the continued adoption of Xywav by patients with narcolepsy.

   Epidiolex/Epidyolex (cannabidiol):

   Epidiolex/Epidyolex net product sales increased 22% to $196.2 million in 3Q22 compared to the same period in 2021.

   The Company successfully completed the pricing and reimbursement process for Epidyolex in France and expects commercial launch by the end of 2022, which would make Epidyolex commercially available and reimbursed in all five key European markets: United Kingdom, Germany...