In addition these albums feature several bonus tracks including John Peel sessions, 7-inch mixes, live tracks and B-sides. The booklet contains quite a number of pictures taken between and and the liner notes written by some band members, provide a wonderful overview of how the albums got together. At the time Gentle Giant's line-up consisted of Gary Green electric guitar, acoustic guitar, string guitar, alto recorder, descant recorder, vocals, percussionKerry Minnear keyboards, cello, vibes, tenor recorder, vocals, percussionDerek Shulman vocals, alto sax, descant recorder, bass, percussionRay Shulman bass, violin, acoustic guitar, descant recorder, trumpet, vocals, percussion and John Weathers drums, vibes, tambour, vocals, percussion. This line-up stayed together until they broke up in
Tsao - Barclays Capital, Inc. Following an introduction from the company, we will open the call to questions. Littrell - Jazz Pharmaceuticals Plc Thank you, Sabrina, and thank you all for joining our investor call. Today, we reported our first quarter financial results and updated our financial guidance.
The press release and the slide presentation accompanying this call are available in the Investors section of our website.
Examples of forward-looking statements include those related to our future financial and operating results, including financial guidance and goals, corporate development efforts, future growth and growth strategy, future product sales and volumes, litigation, and intellectual property-related events, inventory and supply challenges, product launches, regulatory submissions, ongoing and future clinical trials, and other product development and regulatory activities, and the timing of Let them call it jazz matters.
These forward-looking statements involve risks and uncertainties that could cause actual events, performance and results to differ materially. We undertake no duty or obligation to update our forward-looking statements. We believe these non-GAAP financial measures are helpful in understanding our past financial performance and potential future results.
They are not meant to be considered in isolation or as a substitute for comparable reported GAAP measures. Cozadd - Jazz Pharmaceuticals Plc Good afternoon, everyone, and thank you for joining us. We had a strong start to with continued progress in our pre-clinical and clinical programs and the successful accomplishment of multiple regulatory milestones.
Our focus on driving performance of our key products resulted in robust Xyrem net sales and continued growth in demand for Vyxeos in the first quarter of And last month, we submitted our supplemental NDA for Xyrem for pediatric narcolepsy patients with cataplexy and excessive daytime sleepiness.
Finally, we remain on track with an accelerated assessment for Vyxeos in the EU leading to a potential approval this summer and with our planned submission of an MAA for solriamfetol in the EU by year-end.
In the first quarter, we observed growing Vyxeos demand from key academic institutions and expanding use among community hospitals. Since launch, accounts have ordered Vyxeos with academic centers representing the largest segment in volume. Three-quarters of the top 75 target accounts have ordered product and we are pleased with the formulary placement in these important teaching centers.
This is a promising time for AML patients with the recent introduction of multiple new therapeutic agents into the market. KOLs and many AML treaters strongly support the use of Vyxeos in its studied population, and pharmacy directors are working to integrate these new agents into their AML protocols and pharmacy budgets.
Our field teams are also concentrating on ensuring that the clinical superiority of Vyxeos in high-risk AML patients and value proposition are well understood by pharmacy directors and other stakeholders in each institution.
We believe that there is significant upside opportunity for Vyxeos growth as we increase demand in our top academic accounts and further prioritize community hospitals. With respect to the EU, our Vyxeos team is preparing for potential approval.
This launch will be an ongoing process rather than a onetime event as we first need to obtain pricing and reimbursement in each country. We expect that our EU launch of Vyxeos will occur in waves, beginning in countries with the opportunity for favorable early market access, such as the UK, Germany, Austria, the Netherlands and the Nordic countries.
Our plan includes generating data through multiple avenues to support the use of Vyxeos as the new therapeutic foundation in high-risk AML.
We also expect to expand research into other hematological malignancies such as MDS. We look forward to sharing more details on our progress later this year when we anticipate the protocols and contracts will be finalized to support a broad clinical data generation plan through support of ISTs, cooperative group studies and Jazz-sponsored studies.
Our new and dedicated adult transplant team in the U. The team continues to focus on VOD-related educational efforts. We believe we are making progress on this front as our recent market research indicates that physicians are beginning to recognize, diagnose and treat VOD earlier.
On the development side, our Phase 3 study in prevention of VOD and our Phase 2 study in prevention of acute graft-versus-host disease are enrolling patients. The protocol for our planned pivotal study for the treatment of TA-TMA will be finalized following feedback from FDA and scientific advice from the EMA with site activation expected in the fourth quarter.
Now onto our sleep therapeutic area starting with Xyrem and the low sodium oxybate programs. We believe that the underlying early indicators observed in late translated into strong volume growth in early During the first quarter, the Xyrem central pharmacy successfully navigated the typical heavy payer churn and we observed consistent high payer reimbursement approval rates.
The educational efforts of our field reimbursement team continued to impact the approval rates for prior authorizations in key accounts across the country. Our disease awareness education efforts in are leading to increased diagnosis of new narcolepsy patients.
The narcolepsy diagnosis rate for full-year reversed a downward trend with an uptick in diagnosis rates once again. As a reminder, inour disease awareness program ran for six months. Our program is underway and will run the full year.
The observed positive trends in newly diagnosed narcolepsy rates and commercial metrics, such as patient enrollments and first-time prescription fills, support our belief that we can continue to generate volume growth in and beyond. Turning to a brief legal and intellectual property update on Xyrem and an update on progress around the U.
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