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Phunware Inc.

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  16. forum rang 7 Jager63 11 mei 2023 07:43

    • Jager63

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    Pharming Group reports financial results for the first quarter of 2023
    FDA approval and commercial launch of Joenja® (leniolisib) in the U.S.
    Joenja® launch off to strong start with 23 U.S. patients on paid therapy
    Revenues decreased by 9% to US$42.5 million, compared to the first quarter of 2022, primarily due to temporary reimbursement disruptions for some patients on government insurance programs. This issue, affecting all of the HAE market, has since resolved
    Continue to anticipate low single digit growth in annual revenues from RUCONEST® in 2023
    Continued significant investments made in leniolisib launch preparations and organizational structure
    Overall cash balance of US$184.8 million at the end of the quarter
  17. forum rang 7 Jager63 11 mei 2023 07:47

    • Jager63

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    Leiden, The Netherlands, May 11, 2023
    Pharming Group N.V. ("Pharming" or "the Company") (Euronext: PHARM/Nasdaq: PHAR) presents its preliminary, unaudited financial report for the first quarter ended March 31, 2023.

    Chief Executive Officer, Sijmen de Vries, commented:
    "In the first quarter of 2023, we reached an important milestone with the approval and launch of Joenja® (leniolisib), the first and only approved treatment for patients with APDS in the United States. With this approval, U.S.-based patients living with APDS now have access to the medication to normalize their underlying immune function, and Pharming is one step closer to its goal of becoming a leading global rare disease company dedicated to patient communities with unmet medical needs.

    The launch of Joenja® is off to a strong start. In April, we announced that the first commercial product had been shipped to patients with payor reimbursement and we can confirm that we now have 23 patients on paid therapy.

    Turning to RUCONEST®, as we guided on our 2022 full year results call on March 16, we continue to anticipate low single digit revenue growth with quarterly fluctuations. In the first quarter, there were a number of fluctuations that impacted RUCONEST® revenues and the HAE market across acute and prophylactic products. These factors were mainly due to disruptions in reimbursement for some patients on government insurance programs, which delayed shipments.

    These impacts to the business have since resolved and we can confirm that we have seen a recovery and catch up in revenues. Additionally, we are observing strong underlying in-market demand for RUCONEST® and have a high number of new patient enrollments in the U.S. as we entered the second quarter of this year.

    Looking ahead, we continue to progress leniolisib through regulatory pathways in Europe, the U.K. and Japan and expect a positive opinion from the European regulator in the second half of 2023, with Europe and U.K. approvals following approximately two months later.

    We also began the first of two pediatric clinical trials for children with APDS, whom we believe account for some 25% of U.S.-based APDS patients. The first trial for ages 4 to 11 began in February with the second, for children ages 1 to 6, to follow in the third quarter of this year. These pediatric trials, as well as the development of further leniolisib indications, will add to Pharming's pipeline.

    Finally, with a focus on rare disease assets, we are continuously investigating in-licensing and acquisition opportunities which can further enhance our portfolio"
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