Pharming Group Nv · EURONEXT:PHARM
Pharming Group Nv — Shareholder Meeting (May 2022)
66 slides from Pharming Group Nv's shareholder meeting presentation, May 18, 2022
Slide 1: Pharming Group NV Annual General Meeting 2022
Pharming Group NV Annual General Meeting 2022 18 May 2022
Slide 2: Agenda
Agenda 1. Opening and announcements 2. Annual Report 2021 (voting and discussion items) a) Explanation of the business, the operations and the results for the year ending on 31 December 2021 (discussion item) b) Remuneration report for 2021 (advisory voting item) c) Corporate Governance (discussion
Slide 3: Agenda
Agenda 1. Opening and announcements 2. Annual Report 2021 (voting and discussion items) a) Explanation of the business, the operations and the results for the year ending on 31 December 2021 (discussion item) b) Remuneration report for 2021 (advisory voting item) c) Corporate Governance (discussion
Slide 4: Agenda
Agenda 1. Opening and announcements 2. Annual Report 2021 (voting and discussion items) a) Explanation of the business, the operations and the results for the year ending on 31 December 2021 (discussion item) b) Remuneration report for 2021 (advisory voting item) c) Corporate Governance (discussion
Slide 5: Pharming Group NV Annual Report 2021
Pharming Group NV Annual Report 2021 Annual General Meeting May 2022
Slide 6: 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 7: Operational highlights
Operational highlights Leniolisib Reported positive top-line from the pivotal Phase II/III study of leniolisib for the treatment of APDS, with the study meeting both primary endpoints and demonstrating clinical efficacy over placebo Launched genetic testing program ‘navigateAPDS’ in collaboration wi
Slide 8: Execution delivering future growth
Execution delivering future growth 8
Slide 9: Three-pillar objectives to build a fully integrated sustainable business
Three-pillar objectives to build a fully integrated sustainable business Near-term expansion of portfolio within Long-term identification and Grow our global fully integrated our rare/ultra-rare in-house expertise to development of solutions for patients commercial infrastructure grow our business w
Slide 10: HAE & RUCONEST®
HAE & RUCONEST® Ongoing strong sales performance supporting future investment in long-term growth
Slide 11: RUCONEST® positioning in the treatment of HAE
RUCONEST® positioning in the treatment of HAE HAE is caused by a deficiency of C1-INH, resulting in attacks of Convenience market severe swelling (angioedema) in various parts of the body (Prophylactic therapies) Patients use medication for treatment and prevention (prophylaxis) of attacks RUCONEST®
Slide 12: Ongoing demand for acute therapy following stabilization of prophylactic market
Ongoing demand for acute therapy following stabilization of prophylactic market Based on partial payer data, that we estimate represents ~25% of the market 12 Source: Payer sourced Claims through Dec ‘21.
Slide 13: APDS & leniolisib
APDS & leniolisib Expanding our commercial portfolio and leveraging our existing infrastructure to drive growth
Slide 14: PI3Kδ hyperactivity leads to APDS symptoms
PI3Kδ hyperactivity leads to APDS symptoms Common Symptoms of APDS4,5 Excess of immature or senescent cells Deficit of functional cells Severe, Recurrent, Hyperactive Persistent Infections: • Sinopulmonary PI3Kδ activity • Herpesvirus (especially EBV and CMV) Lymphoproliferation: • Lymphadenopathy B
Slide 15: Pivotal trial design
Pivotal trial design1,2 Part 1 Part 2 – Randomized, triple-blinded (patient, Dose-finding Placebo-controlled caregiver, investigator), placebo- controlled, fixed-dose study Randomized period 12 weeks Co-primary efficacy endpoints 12 weeks (lymphadenopathy and N=6 N=31 immunophenotype normalization)
Slide 16: Patient demographics – safety analysis
Patient demographics – safety analysis Leniolisib (n=21) Placebo (n=10) Total (N=31) Age Median (range), years 20.0 (12-54) 19.5 (15-48) 20.0 (12-54) < 18 years, n (%) 8 (38.1) 4 (40.0) 12 (38.7) Sex: Male/female, % 52.4/47.6 40.0/60.0 48.4/51.6 Weight: Median (range), kg 67.1 (46.9-100.6) 68.9 (50.
Slide 17: Leniolisib reduced lymphadenopathy
Leniolisib reduced lymphadenopathy Change from baseline at day 85 in log10 transformed SPD* in index lesions (n=26†) 0.1 0.05 Leniolisib Placebo 0 n=18 n=8 Adjusted Mean Change (log10 SPD) -0.05 -0.1 -0.06 -0.15 -0.2 -0.25 -0.3 -0.35 -0.30 -0.4 ** p=0.0012 Data were analyzed using ANCOVA model with
Slide 18: Additional analysis: SPD of index lesions by patient
Additional analysis: SPD of index lesions by patient in PD data Change from baseline at day 85 in SPD of index lesions (n=28) 60 53.83 40.53 40 20 10.27 Change from Baseline (%) 0 -4.72 -6.53 -8.89 -20 -14.37 -17.45 -24.97 -30.38 -30.90 -31.86 -33.70-34.07 -40 -35.09 -36.27 -37.84 -40.41 -43.12 -45.
Slide 19: Supportive analysis: naïve B cells
Supportive analysis: naïve B cells 90 Absolute percentage of cells over time† Change from baseline at day 85 in naïve B 80 cells (n=21*) 40 70 *** 35 27.87 p=0.0005 60 30 Adjusted Mean Change (%) 50 Naïve B Cells (%) 25 20 40 15 30 10 0.92 5 20 n=13 n=8 0 Leniolisib Placebo 10 -5 -10 0 Baseline Day
Slide 20: Leniolisib reduced spleen and liver size
Secondary and exploratory analyses: leniolisib reduced spleen and liver size Spleen Liver Change from baseline at day 85 in bi- Change from baseline at day 85 in bi- dimensional spleen size (n=27) dimensional liver size (n=28) 1000 ** 410.48 4000 Adjusted Mean Change (mm2) p=0.0079 * p=0.0416 1547.5
Slide 21: Leniolisib over three months was well tolerated
Leniolisib over three months was well tolerated Leniolisib (n=21) Placebo (n=10) Total (N=31) nE, nS (%)* nE, nS (%) nE, nS (%) AEs, Patients with AEs 92, 18 (85.7) 46, 9 (90.0) 138, 27 (87.1) Grade 1 AEs 65, 15 (71.4) 27, 8 (80.0) 92, 23 (74.2) Grade 2 AEs 19, 9 (42.9) 13, 5 (50.0) 32, 14 (45.2) Gr
Slide 22: Long term leniolisib results (N=6)
Long term leniolisib results (N=6) 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 22 Slide courtesy of Dr V. Koneti Rao. Leniolisib is an investigational new drug
Slide 23: Launch preparations: Uncovering APDS
Launch preparations: Uncovering “APDS” US targeted patient identification strategy 1. 2. 3. BUILD APDS OUTREACH & ANALYTICS & AI NETWORK EDUCATION Genetic Testing The US has created a KOL network Patient identification using ‘Free of charge’ genetic testing, & referral pathway of prescribers sophist
Slide 24: Next steps: upcoming milestones
Next steps: upcoming milestones* Anticipated FDA Initiation of Anticipated US Anticipated EU filing pediatric studies regulatory approval regulatory approval H1 2022 H2 2022 H1 2023 H2 2023 Anticipated Anticipated EMA Initiation of Anticipated US commercial EU and MHRA filings Japanese clinical tria
Slide 25: HAE & OTL-105
HAE & OTL-105 Grow and extend our HAE franchise
Slide 26: OTL-105: developing a best-in-class HAE gene therapy
OTL-105: developing a best-in-class HAE gene therapy Collaboration with Orchard Therapeutics to develop and commercialize an ex vivo autologous hematopoietic stem cell (HSC) gene therapy for HAE OTL-105 inserts one or more functional copies of the SERPING1 gene into patients own HSCs ex vivo which a
Slide 27: The HSC gene therapy approach
The HSC gene therapy approach 5. The gene-corrected 1. Cells are collected cells are infused into from the patient the patient 2. Blood stem cells are selected and purified 4. The patient is conditioned to receive treatment 3. A working copy of the gene is inserted into the cells using a viral vecto
Slide 28: HSC gene therapy has led to multiple approved and effective products
HSC gene therapy has led to multiple approved and effective products Modality HSC Gene Therapy AAV- GT Gene Editing - Multiple products - No liver-directed AAV is - No approved products approved and pipeline approved with impressive data - Selectivity for specific Proven Approach - HSC GT and CAR-T
Slide 29: Environmental, Social & Governance (ESG)
Environmental, Social & Governance (ESG)
Slide 30: ESG
ESG % Pharming KEY ELEMENTS 2022 Developing an ESG program to build a sustainable business. Establishing an ESG committee To establish a strong ESG committee with decision making capabilities, we will bring together key employees within Pharming, who will help ensure a unified view of ESG and genera
Slide 31: Financial Review
% Pharming Financial Review
Slide 32: Financial highlights
Financial highlights Revenue for the full year 2021 were US$198.9 million, a 6% decrease from US$212.2 million in 2020. Gross profit for 2021 was US$177.7 million, a 6% decrease in comparison to 2020 (US$188.6 million), in line with the decrease in revenues. Operating profit of US$36.9 million in 20
Slide 33: Financial highlights: Profit before tax development 2020 – 2021
Financial highlights: Profit before tax development 2020 – 2021 (US$ Million) 44.1 -10.9 -13.1 4.1 23.1 -10.2 4.3 -14.0 34.1 -7.5 -7.8 Profit Underlying OTL-105 Impairment Increase Increased Increased FX effect Orbimed loan Other Profit before tax business investment tangible and in R&D SG&A M&S set
Slide 34: Income statement – operating result
Income statement – operating result Amounts in US$ ‘000 2021 2020 Revenues 198,871 212,174 Costs of sales (21,142) (23,539) Gross profit 177,729 188,635 Other income 2,620 1,829 Research and development (70,369) (38,519) General and administrative (36,974) (24,805) Marketing and sales (59,445) (51,6
Slide 35: Income statement – net result
Income statement – net result Amounts in US$ ‘000 2021 2020 Operating profit 13,561 76,256 Fair value gain (loss) on revaluation derivatives 114 69 Other finance income 14,906 715 Other finance expenses (6,196) (33,308) Finance result, net 8,824 (32,524) Share of net profits in associates using the
Slide 36: Balance sheet – assets
Balance sheet – assets Amounts in US$ ‘000 2021 2020 Non-current assets Intangible assets 83,834 94,083 Property, plant and equipment 13,222 12,226 Right-of-use assets 19,943 9,427 Long-term prepayments 194 0 Deferred tax assets 21,216 31,877 Investment accounted for using the equity method 7,201 7,
Slide 37: Balance sheet – liabilities
Balance sheet – liabilities Amounts in US$ ‘000 2021 2020 Equity Share capital 7,282 7,165 Share premium 453,190 445,066 Legal reserves 2,172 19,859 Accumulated deficit (269,727) (288,655) Shareholders’ equity 192,917 183,435 Non-current liabilities Convertible bonds 139,007 149,727 Lease liabilitie
Slide 38: Cash development 1 January 2021 – 31 December 2021
Cash development 1 January 2021 – 31 December 2021 (US$ Million) -4.9 42.8 -21.3 -2.9 -25.0 -1.9 205.2 191.9 Cash and cash Operating cash Total changes in Net cash Net cash flows Exchange rate Cash and cash equivalents on flow before working capital flows used in generated from effects equivalents o
Slide 39: Cash flow
Cash flow Amounts in US$’000 2021 2020 Profit before tax 23,079 44,094 Net cash flows generated from (used in) operating activities 37,843 83,626 Capital expenditure for property, plant and equipment (10,739) (4,657) Investment intangible assets (3,447) (9,060) Investment associate 0 (329) Investmen
Slide 40: Outlook for full year 2022
% Pharming Outlook for full year 2022 40
Slide 41: Outlook for 2022
Outlook for 2022 For Athe return remainder to single of digit 2022,growth the Company in Groupexpects: revenues from RUCONEST® sales, driven by the US and expanded EU operations, subject to the progression of the COVID-19 pandemic. Quarterly fluctuations in revenues are expected. A return to single
Slide 42: Agenda
Agenda 1. Opening and announcements 2. Annual Report 2021 (voting and discussion items) a) Explanation of the business, the operations and the results for the year ending on 31 December 2021 (discussion item) b) Remuneration report for 2021 (advisory voting item) c) Corporate Governance (discussion
Slide 43: 2. b) Remuneration Report 2021
2. b) Remuneration Report 2021 • The implementation of the Company's remuneration policy in 2021 for members of the Board of Directors has been outlined in the section Remuneration Report 2021 of the Company's Annual Report for the financial year 2021. • The Remuneration Report for 2021 takes into c
Slide 44: 2. b) Remuneration Report 2021 (continued)
2. b) Remuneration Report 2021(continued) CEO remuneration package Fixed annual salary 2021: EUR 574,000 Short-term Incentive plan 2021: o total score on targets: 75% o payout in cash of gross amount equal to 52,5% gross annual salary (on target: 70% annual salary) One-off transition arrangeme
Slide 45: 2. b) Advisory voting: Remuneration Policy
2. b) Advisory voting: Remuneration Policy 45
Slide 46: Agenda
Agenda 1. Opening and announcements 2. Annual Report 2021 (voting and discussion items) a) Explanation of the business, the operations and the results for the year ending on 31 December 2021 (discussion item) b) Remuneration report for 2021 (advisory voting item) c) Corporate Governance (discussion
Slide 47: Dutch Corporate Governance Code
Dutch Corporate Governance Code • Remaining deviations: • 1.3-1.7 (Internal auditor) • 3.3.2 (Shares for the Non-Executive Directors as part of remuneration) • 4.2.3 (System to follow all meetings in real time) • Details can be found in the section ‘Dutch Corporate Governance Code’ in the 2021 Annua
Slide 48: Agenda
Agenda 1. Opening and announcements 2. Annual Report 2021 (voting and discussion items) a) Explanation of the business, the operations and the results for the year ending on 31 December 2021 (discussion item) b) Remuneration report for 2021 (advisory voting item) c) Corporate Governance (discussion
Slide 49: 2. d) Explanation of the dividend policy
2. d) Explanation of the dividend policy The Board of Directors, will transfer the net profit for the year of 2021 to the accumulated deficit. 49
Slide 50: Agenda
Agenda 1. Opening and announcements 2. Annual Report 2021 (voting and discussion items) a) Explanation of the business, the operations and the results for the year ending on 31 December 2021 (discussion item) b) Remuneration report for 2021 (advisory voting item) c) Corporate Governance (discussion
Slide 51: Overview of the Deloitte audit
Overview of the Deloitte audit COMMUNICATION - Several meetings and calls with Board of Directors / Audit Committee FINANCIAL STATEMENTS - Audit plan, management letter AND MANAGEMENT REPORT and year-end report - Unqualified auditor’s report signed April 6, 2022 - Management Report, MATERIALITY Gove
Slide 52: 2. e) Proposal to adopt the Financial Statements
2. e) Proposal to adopt the Financial Statements 52
Slide 53: 2. e) Voting Results
% Pharming 2. e) Voting Results 53
Slide 54: Agenda
Agenda 1. Opening and announcements 2. Annual Report 2021 (voting and discussion items) a) Explanation of the business, the operations and the results for the year ending on 31 December 2021 (discussion item) b) Remuneration report for 2021 (advisory voting item) c) Corporate Governance (discussion
Slide 55: 2. f) Proposal to discharge the members of the Board of Directors
2. f) Proposal to discharge the members of the Board of Directors for their responsibilities 55
Slide 56: 2. f) Voting Results
% Pharming 2. f) Voting Results 56
Slide 57: Agenda
Agenda 1. Opening and announcements 2. Annual Report 2021 (voting and discussion items) a) Explanation of the business, the operations and the results for the year ending on 31 December 2021 (discussion item) b) Remuneration report for 2021 (advisory voting item) c) Corporate Governance (discussion
Slide 58: 3. Designation of the Board of Directors as the Company's body authorized to issue shares
3. Designation of the Board of Directors as the Company’s body authorized to: (i) issue shares, (ii) grant rights to acquire rights and (iii) to limit or exclude pre-emptive rights (voting items): 3.a: General authorization for generic corporate purposes, including (i) share issuances to the Board o
Slide 59: 3. Voting Results
3. Voting Results 3.a: 3.b: 59
Slide 60: Agenda
Agenda 1. Opening and announcements 2. Annual Report 2021 (voting and discussion items) a) Explanation of the business, the operations and the results for the year ending on 31 December 2021 (discussion item) b) Remuneration report for 2021 (advisory voting item) c) Corporate Governance (discussion
Slide 61: 4. Authorization of the Board of Directors to repurchase shares in the Company
4. Authorization of the Board of Directors to repurchase shares in the Company Proposal to authorize the Board of Directors for a period of eighteen months starting on 18 May 2022 as the body which is authorized, to repurchase not more than 10% of the issued capital through the stock exchange or oth
Slide 62: 4. Voting Results
% Pharming 4, Voting Results 62
Slide 63: Agenda
Agenda 1. Opening and announcements 2. Annual Report 2021 (voting and discussion items) a) Explanation of the business, the operations and the results for the year ending on 31 December 2021 (discussion item) b) Remuneration report for 2021 (advisory voting item) c) Corporate Governance (discussion
Slide 64: 5. Any other business
% Pharming 5. Any other business 64
Slide 65: Agenda
Agenda 1. Opening and announcements 2. Annual Report 2021 (voting and discussion items) a) Explanation of the business, the operations and the results for the year ending on 31 December 2021 (discussion item) b) Remuneration report for 2021 (advisory voting item) c) Corporate Governance (discussion
Slide 66: Tickers and investor contact
Tickers: • Euronext Amsterdam: PHARM • Nasdaq: PHAR investor@pharming.com 66