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Pharming N.V.(PHAR) - 2021 Q4 - Annual Report
2022-04-06 20:07
Revenue Performance - Revenues from the sale of RUCONEST® for the treatment of acute HAE attacks were US$198.9 million in 2021, a decrease of 6.3% from US$212.2 million in 2020[420][441] - The U.S. market accounted for US$193.4 million of RUCONEST® sales in 2021, down from US$202.7 million in 2020, primarily due to the impact of the COVID-19 pandemic[441][444] - Revenue in Europe decreased to US$4.9 million in 2021 from US$8.2 million in 2020, attributed to phasing of ordering[442] - Two U.S. customers represented 79% of total revenues in 2021, highlighting reliance on a limited customer base[443] Operating Profit and Costs - Operating profit for 2021 was US$13.6 million, a significant decrease from US$76.3 million in 2020[440] - Cost of sales decreased by US$2.4 million, or 10.2%, from US$23.5 million in 2020 to US$21.1 million in 2021, with product sales costs at US$19.1 million[445] - Gross profit decreased by US$10.9 million, or 5.8%, from US$188.6 million in 2020 to US$177.7 million in 2021, primarily due to reduced sales in the U.S. and EU[448] Research and Development - The company is developing rhC1INH for additional indications, including pre-eclampsia and AKI, which may require significant investment and regulatory approval[422] - The leniolisib Phase 2/3 clinical trial has been completed, and the company plans to submit a New Drug Application (NDA) to the FDA in mid-2022[423] - The company incurred research and development costs of US$70.4 million in 2021, up from US$38.5 million in 2020, reflecting increased investment in product development[440] - Research and development expenses increased by US$31.9 million, or 82.7%, from US$38.5 million in 2020 to US$70.4 million in 2021, mainly due to investments in clinical studies[452] Administrative and Marketing Costs - General and administrative costs increased by US$12.9 million, or 53.5%, from US$24.1 million in 2020 to US$37.0 million in 2021, largely due to impairment losses and additional administrative resources[454] - Marketing and sales costs increased by US$7.8 million, or 15.2%, from US$51.6 million in 2020 to US$59.4 million in 2021, driven by expansion in the U.S. and Europe[455] Financial Performance and Cash Flow - Other income related to grants increased by US$0.8 million, or 43.2%, from US$1.8 million in 2020 to US$2.6 million in 2021[451] - Other finance income surged by US$14.2 million, or 1983.1%, from US$0.7 million in 2020 to US$14.9 million in 2021, primarily due to favorable currency effects[460] - Other finance expenses decreased by US$27.1 million, or 81.4%, from US$33.3 million in 2020 to US$6.2 million in 2021, attributed to currency exchange rate changes and absence of settlement fees[463] - Income tax expense increased by US$0.7 million, or 11.6%, from US$6.3 million in 2020 to US$7.1 million in 2021, despite lower profit before tax[467] - Net cash flows generated from operating activities were US$37.8 million in 2021, down from US$83.6 million in 2020[515] - The company anticipates that sales of RUCONEST® will continue to cover operating costs and finance costs in 2022[513] Capital Expenditures and Financing - Net cash flows used in investing activities increased to US$21.3 million for the year ended December 31, 2021, compared to US$15.6 million in 2020, primarily due to capital expenditures of US$10.7 million[519] - The company experienced a net cash outflow of US$27.9 million from financing activities for the year ended December 31, 2021, a significant change from a net cash inflow of US$60.7 million in 2020, mainly due to the absence of proceeds from convertible bonds[521] - The company issued €125 million of 3.00% convertible bonds due 2025 on January 21, 2020, with net proceeds used to redeem US$51 million of a loan and support capital expenditures[523] - Capital expenditures in 2021 were primarily related to investments in new production facilities and machinery, totaling US$10.7 million[519] Future Outlook and Risks - The company expects an increase in research and development and administrative costs due to ongoing clinical trials and product development[509] - The company may consider raising capital through equity or debt to support acquisitions or in-licensing of additional assets if favorable terms are available[514] - The company expects to continue facing uncertainties due to the ongoing COVID-19 pandemic, which may impact future sales growth[424] - The company’s financial risks include liquidity, market risk, and credit risk, with the Board responsible for risk management policies[692]
Pharming Group N.V. (PHGUF) CEO Sijmen Vries on Full Year 2021 Results - Earnings Call Transcript
2022-03-17 20:14
Pharming Group N.V. (OTCPK:PHGUF) Full Year 2021 Earnings Conference Call March 17, 2022 9:00 AM ET Company Participants Sijmen Vries - Executive Director and Chief Executive Officer Jeroen Wakkerman - Chief Financial Officer Anurag Relan - Chief Medical Officer Conference Call Participants Hartaj Singh - Oppenheimer & Co Joe Pantginis - H.C. Wainright Alex Cogut - Kempen Christian Glennie - Stifle Operator Hello and welcome to Pharming’s Full Year 2021 Results call. My name is Jordan and I’ll be coordinat ...
Pharming N.V.(PHAR) - 2021 Q3 - Earnings Call Transcript
2021-10-29 21:46
Financial Data and Key Metrics Changes - The company reported sales of over $146 million for RUCONEST in the first nine months of 2021, with a 6% increase in sales from Q2 2021 [4][58] - Year-to-date sales showed a 4% decrease compared to the previous year, primarily due to the impact of COVID-19 on the U.S. healthcare economy [58] - Gross profit increased by 4%, maintaining a stable gross margin of around 89% [61] - Net profit for the first three quarters was $13.9 million, reflecting a 49% decrease from the previous year due to initial in-licensing costs and increased operating expenses [66] Business Line Data and Key Metrics Changes - RUCONEST remains the primary revenue generator, with ongoing demand despite the introduction of prophylactic products [58][60] - The company is expanding its pipeline with new indications for C1 inhibitor and has in-licensed OTL-105 for hereditary angioedema [8][12] - The anticipated launch of leniolisib for the treatment of APDS is expected by the end of 2022, which is seen as a significant growth opportunity [5][24] Market Data and Key Metrics Changes - The hereditary angioedema market was valued at approximately $2 billion in 2020, with RUCONEST positioned to capture a stable share [16] - The U.S. market is experiencing a shift towards prophylactic treatments, but there remains a need for acute therapies like RUCONEST due to breakthrough attacks [21][23] Company Strategy and Development Direction - The growth strategy is built on three pillars: expanding the HAE franchise, extending the C1 franchise to larger indications, and leveraging commercial infrastructure for new product launches [8][10] - The company is actively seeking to in-license or acquire additional late-stage assets in rare diseases to enhance its portfolio [11][81] - Investments are being made in prelaunch activities for leniolisib and ongoing clinical trials for RUCONEST and other indications [76] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the gradual recovery from COVID-19 and continued growth for RUCONEST in the hereditary angioedema market [20] - The company is monitoring the impact of COVID-19 on clinical trials and is working to expand the number of sites participating in studies [95][96] - There is a focus on obtaining regulatory approvals for RUCONEST in additional countries, with recent progress in Spain and plans for Italy [99][100] Other Important Information - The company has a strong balance sheet with $183 million in cash and cash equivalents at the end of Q3 2021, down from $205 million at the beginning of the year [71] - Significant investments were made in the OTL-105 collaboration, totaling $17.7 million, which includes both operational expenses and share purchases [63][74] Q&A Session Summary Question: Update on OTL-105 manufacturing and timeline to commercial stage - The manufacturing of OTL-105 is still in the preclinical stage, with more information expected in the coming quarters [86] Question: Certainty of leniolisib trial sufficiency for regulatory approval - The pivotal study for leniolisib is designed with regulatory feedback and is expected to meet endpoints that will support potential approval [88][89] Question: Additional indications and impact of COVID on clinical trials - Clinical trials are still facing challenges due to COVID-19, but efforts are being made to expand participation in studies [95][96] Question: Regulatory efforts for RUCONEST in additional countries - The company is selectively pursuing approvals and reimbursements in new territories, including recent progress in Spain and plans for Italy [99][100]
Pharming N.V.(PHAR) - 2021 Q2 - Earnings Call Transcript
2021-08-09 02:20
Pharming Group N.V. (OTCPK:PHGUF) Q2 2021 Earnings Conference Call August 5, 2021 1:00 PM ET Company Participants Sijmen De Vries - Chief Executive Officer Jeroen Wakkerman - Chief Financial Officer Conference Call Participants Joe Pantginis - Wainwright Alex Cogut - Kempen Christian Glennie - Stifel Sijmen De Vries Good afternoon, ladies and gentlemen. I'm sitting here with Chief Financial Officer, Jeroen Wakkerman to take you through the half year results 2021. But before I do that, next slide, please, I ...
Pharming N.V.(PHAR) - 2020 Q4 - Annual Report
2021-04-07 20:22
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF ...