Slide 1: H1 2022 Financial Results Analyst Call
Pharming Group N.V. H1 2022 Financial Results Analyst Call August 4, 2022 NASDAQ: PHAR | EURONEXT Amsterdam: PHARM
Slide 2: Forward looking statements
Forward looking statements This presentation may contain forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future
Slide 3: Speakers
SPEAKERS Sijmen de Vries Anurag Relan Jeroen Wakkerman Chief Executive Officer Chief Medical Officer Chief Financial Officer
Slide 4: Strategic and operational highlights
CEO Sijmen de Vries Chief Executive Officer Strategic and operational highlights
Slide 5: Pharming's strategic objectives
Pharming’s strategic objectives Building a sustainable business by focusing on RUCONEST® sales Focus on Market approval, launch and commercialization of leniolisib in key markets of US, UK and EEA Ongoing pipeline development and management of rare disease assets 5
Slide 6: Continuing to build a sustainable business in rare diseases
Continuing to build a sustainable business in rare diseases Building a sustainable business by Anticipated approval and Ongoing pipeline development and focusing on RUCONEST® sales commercialization of leniolisib management of rare disease assets Positive cash flow from Successful commercialization
Slide 7: Strategic highlights: leniolisib progress
Strategic highlights: leniolisib progress We remain on track for the commercial approval of leniolisib in the US, UK and the EU USA UK / EU Pharming receives positive EMA decision on pediatric investigation plan (PIP) Filing of New Drug Authorization with the FDA for leniolisib in Europe JAN 6 JUL 2
Slide 8: Strategic highlights: OTL-105 & Pompe
Strategic highlights: OTL-105 & Pompe Progress continues in preclinical studies OTL-105 POMPE Significant progress developing the lentiviral vector to enhance C1-inhibitor Study into the development of a next- expression and is now testing in preclinical generation alpha-glucosidase therapy for HAE
Slide 9: Strategic highlights: Acute Kidney Injury and Pre-eclampsia
Strategic highlights: Acute Kidney Injury and Pre-eclampsia After an internal review of our pipeline, decision was made to discontinue further developments in these programs. Strategic options considered to gain value from work done to date. ACUTE KIDNEY INJURY PRE-ECLAMPSIA De-prioritizing of large
Slide 10: Operational highlights: RUCONEST (conestat alfa)
Operational highlights: RUCONEST® (conestat alfa) Market representation RUCONEST® sales of (total revenues) US$96.8 million in H1 2022 US sales – 97% EU & RoW – 3% RUCONEST® sales growth Stable revenues. Will allocate supported by an increase in resources to leniolisib with physicians prescribing an
Slide 11: APDS and leniolisib
CMO Anurag Relan Chief Medical Officer APDS and leniolisib
Slide 12: Clinical Features of APDS
Clinical Features of APDS Overt Non-malignant Lymphoproliferation Malignant Lymphadenopathy – peripheral, Hepatosplenomegaly Nodular lymphoid hyperplasia of the airway and GI mucosa Lymphoproliferation mediastinal, mesenteric Lymphoma – diffuse large B cell, Hodgkin’s, marginal zone B cell, MALToma,
Slide 13: Leniolisib reduced lymphadenopathy
Leniolisib reduced lymphadenopathy Primary Outcome Analysis* Individual Index Lesion Sizes Change from baseline in index lesions Safety analysis set 0.1 SPD of Index Lymph Node Lesions CFB at D85 in log10-Transformed 0.0 n=8 n=18 -0.1 -0.02 -0.2 -0.27 -0.3 *** *** p=0.0006 -0.4 Leniolisib Placebo n=
Slide 14: Leniolisib Increased the Percentage of Naïve B Cells
Leniolisib Increased the Percentage of Naïve B Cells Out of Total B Cells Primary Outcome Analysis* Mean Percentage of Naïve B Cells Over Time Change from baseline in naïve B cells Safety analysis set p=0.0002 50 80 *** 66.52 Total CD19+ B Cells (%) 65.80 61.81 40 CFB at D85 in Naïve B Cells/Total B
Slide 15: Leniolisib over three months was well tolerated
Leniolisib over three months was well tolerated 100 Patients with AEs Percentage of Patients, % 90.0 85.7 80.0 Grade 1 80 71.4 Grade 2 60 Grade 3 50.0 42.9 Grade 4 40 Study drug- 30.0 30.0 23.8 20.0 related AEs 20 14.3 9.5 9.5 10.0 SAEs 0 Leniolisib (n=21) Placebo (n=10) Number of AEs 92 65 19 3 3 6
Slide 16: Long term leniolisib results (N=6)
Long term leniolisib results (N=6) Leniolisib is an investigational new drug that has not been approved for any use. Patients have stopped (*) or decreased (§) immunoglobulin supplementation as a reflection of the normalization of their B cell function. Dashed lines indicate patient not on treatment
Slide 17: Upcoming milestones for leniolisib
Upcoming milestones for leniolisib* JULY 29: Filing of New Drug Initiation of Anticipated Anticipated Authorization with pediatric US regulatory EU regulatory the FDA studies approval approval H2 2022 H1 2023 H2 2023 Anticipated Anticipated Anticipated EMA and US commercial commercial MHRA filings l
Slide 18: Financial highlights
CFO Jeroen Wakkerman Chief Financial Officer Financial highlights
Slide 19: Financial highlights
Financial highlights Total revenues up 4% compared to H1 2021 Net profit increased by 33% compared to H1 2021 Positive cash flows, offset by exchange rate effect Stake held by Pharming in BioConnection reduced, received a one-off US$7.5 million cash payment and recognized gain of US$12.8 million. 19
Slide 20: Financial highlights: Q2 2022
Financial highlights: Q2 2022 TOTAL TOTAL REVENUES US$49.7 million REVENUES US$50.1 million Q2 2021 Q2 2022 GROSS GROSS PROFIT US$45.0 million PROFIT US$46.1 million Q2 2021 Q2 2022 OPERATING OPERATING PROFIT US$10.9 million PROFIT US$17.8 million Q2 2021 Q2 2022 NET PROFIT NET PROFIT US$5.8 million
Slide 21: Financial highlights: H1 2022
Financial highlights: H1 2022 TOTAL TOTAL Increased by 4% REVENUES US$93.2 million REVENUES to US$96.8 million (US$ Million) H1 2021 H1 2022 96.8 GROSS GROSS 93.2 Increased by 5% PROFIT US$83.8 million PROFIT to US$87.9 million H1 2021 H1 2022 OPERATING OPERATING 43.6 46.6 Increased by 20% PROFIT US
Slide 22: H1 2022: Profit before tax H1 2021 – H1 2022
H1 2022: Profit before tax H1 2021 – H1 2022 (US$ Million) Profit Underlying Increased Increased Increased Financial Other Profit before tax business R&D G&A M&S result before tax H1 2021 gross profit expenditure expenditure expenditure H1 2022 22
Slide 23: H1 2022: Cashflow January 1, 2022 – June 30, 2022
H1 2022: Cashflow January 1, 2022 – June 30, 2022 (US$ Million) Cash and cash Net cash flows Net cash flows Net cash flows Exchange rate Cash and cash equivalents on generated from generated from generated from effects equivalents on January 1, 2022 (used in) operating (used in) investing (used in)
Slide 24: BioConnection transaction – positive financial impact
BioConnection transaction – positive financial impact Pharming paid €4.1 million for a 43.85% stake in BioConnection APR 2019 All shares in BioConnection were sold, followed by a partial re-investment APR 2022 As a result of the transactions, the stake held by Pharming in BioConnection reduced APR 2
Slide 25: Outlook for the remainder of 2022
Outlook for the remainder of 2022 Single digit growth in Group revenues from RUCONEST® sales, quarterly fluctuations are expected. On track for leniolisib regulatory filings to EMA and UK MHRA in H2 2022. Commercial approval of leniolisib from FDA in Q1 2023, with an anticipated launch and commercia
Slide 26: Q&A
Q&A Sijmen de Vries Anurag Relan Jeroen Wakkerman Chief Executive Officer Chief Medical Officer Chief Financial Officer
Slide 27: Presentation, recording and transcript will be made available
This presentation, a recording and a transcript of this call will be made available on the company’s website. www.pharming.com | investor@pharming.com NASDAQ: PHAR | EURONEXT Amsterdam: PHARM Bloomberg: PHAR.AS
Slide 28: Statement of profit and loss
Statement of profit and loss 28
Slide 29: Balance sheet – assets
Balance sheet — assets Pharming’ moun June 30,2022 Pecem Non-current assets “ Intangible assets 12 75,766 83,834 Property, plant and equipment 13 11,674 13,222 Right-of-use assets 14 18,284 19,943 Long term prepayments F 223 194 Deferred tax assets 15 18,594 21,216 Investments accounted for using th
Slide 30: Balance sheet – liabilities
Balance sheet – liabilities 30
Slide 31: Cash flow (1/2)
Cash flow (1/2) H1 2022 H1 2021 Profit before tax Non-cash adjustments: Depreciation, amortization, impairment 4,263 4,518 Equity settled share-based payments 2,879 3,793 Gain on disposal of investment in associate (12,708), _ Fair value gain (loss) on revaluation of derivatives _ (44) Other finance
Slide 32: Cash flow (2/2)
Cash flow (2/2) Capital expenditure for property, plant and equipment (729 (30 Investment intangible assets (829 (1,206 Investment in associate 7,578 - Acquisition of license = (1,083 [ Net cash flows generated from (use ) investing activities 6,020 (7,725) Payment on contingent consideration - (25,