Power of The Dream Ventures (PWRV) Inactive
Filed: 20 Oct 14, 12:00am
| 2013 | 2014 | 2015 | |
| FCFF | -4,416,972 | 5,855,272 | 86,570,454 |
| (USD) | |||
| Interest rate | NPV | Finance needed | Current value |
| 28% | $ 41,403,024 | $ 16,600,000 | $ 24,803,024 |
| Values in USD | 2013 | 2014 | 2015 | ||
| SUM | SUM | SUM | |||
| INCOME | |||||
| $2,500,000 investment | $ 2,500,000 | $ - | $ - | ||
| $15M 7% bond issue | $ 14,100,000 | $ - | $ - | ||
| CMA income | $ - | $ 28,586,500 | $ 141,851,682 | ||
| EXPENSES | |||||
| GI maintaining existing intellectual property (IP) | $ 115,000 | $ 180,000 | $ 180,000 | ||
| GI new IP | $ 65,000 | $ 120,000 | $ 120,000 | ||
| Product development | |||||
| Allergy Phase II | $ - | $ 1,500,000 | $ 7,200,000 | ||
| HPV Phase II | $ 55,000 | $ 1,500,000 | $ 7,200,000 | ||
| Prostate cancer Phase II | $ - | $ 1,500,000 | $ 4,800,000 | ||
| pACTG | $ - | $ 600,000 | $ 1,200,000 | ||
| Antibiotics I/II | $ - | $ 1,500,000 | $ 4,800,000 | ||
| MAGE programme phase II | $ - | $ 1,500,000 | $ 7,200,000 | ||
| Hepatitis B phase II | $ - | $ 1,500,000 | $ 4,800,000 | ||
| Hepatitis C phase II | $ - | $ 1,500,000 | $ 4,800,000 | ||
| EMA Conditional Marketing Approval (CMA) | |||||
| German CRO | $ 284,800 | $ 600,000 | $ 600,000 | ||
| German Product development | $ 43,560 | $ 47,520 | $ 47,520 | ||
| Professional consultancy | $ 43,560 | $ 47,520 | $ 47,520 | ||
| EMA consultancy I | $ 10,600 | $ - | $ - | ||
| EMA consultancy II | $ 5,293 | $ - | $ - | ||
| Official authority control (GMP, Laboratory, etc.) | $ 13,960 | $ - | $ - | ||
| CMA issuing fee | $ 356,400 | $ - | $ - | ||
| Yearly CMA fee | $ - | $ 126,588 | $ 126,588 | ||
| $ - | $ - | $ - | |||
| Vaccine production | $ 680,000 | $ 1,200,000 | $ 1,200,000 | ||
| DermaPrepp production | $ 980,000 | $ 1,470,000 | $ - | ||
| GI lab and real estate | $ 105,000 | $ 600,000 | $ 600,000 | ||
| DNA production facility | $ - | $ 1,200,000 | $ 1,200,000 | ||
| Marketing | $ 10,000 | $ 600,000 | $ 600,000 | ||
| Other costs / consultancy, etc. | $ 120,000 | $ 1,400,000 | $ 3,000,000 | ||
| Operational costs | |||||
| Facilities | $ 120,000 | $ 240,000 | $ 240,000 | ||
| Charges | $ 24,000 | $ 48,000 | $ 48,000 | ||
| SEC lawyer services | $ 43,000 | $ 96,000 | $ 144,000 | ||
| General legal counsel services | $ 24,000 | $ 64,000 | $ 96,000 | ||
| Travelling costs | $ 60,000 | $ 300,000 | $ 300,000 | ||
| Insurance | $ 36,000 | $ 36,000 | $ 36,000 | ||
| SEC fees | $ 24,000 | $ 24,000 | $ 24,000 | ||
| BDO Audit | $ 45,000 | $ 90,000 | $ 90,000 | ||
| Transportation | $ 72,000 | $ 240,000 | $ 240,000 | ||
| Other operational costs | $ 48,000 | $ 96,000 | $ 96,000 | ||
| PRs | $ 52,800 | $ 105,600 | $ 105,600 | ||
| Current HR costs | $ 840,000 | $ 1,680,000 | $ 1,680,000 | ||
| New labour costs | $ 100,000 | $ 1,020,000 | $ 2,460,000 | ||
| Travel | $ 40,000 | $ - | $ - | ||
| Cash Flow | $ 12,183,028 | $ 5,855,272 | $ 86,570,454 | ||
| Cumulative CF | 12,183,028 | 18,038,300 | 104,608,754 | ||
| First quarter investment requirement: | |||||
| Second quarter investment requirement: | |||||
| Third quarter investment requirement: | |||||
| Fourth quarter investment requirement: |
| 2014 | 2015 | |
| INCOME PLANNED (USD) | $ 28,586,500 | $ 141,851,682 |
| CMA income | ||
| No. Of treated people | 9,839 | 48,823 |
| No. Of treatments | 39,356 | 195,292 |
| Cost / tratment | $ 1,625.00 | $ 1,625.00 |
| Income from treatments | $ 63,953,500 | $ 317,349,500 |
| Cost of goods | $ 198.08 | $ 198.08 |
| Administrative costs | $ 250.63 | $ 250.63 |
| EBITDA | $ 46,293,928 | $ 229,719,324 |
| Dividend | $ 2,314,696 | $ 11,485,966 |
| EBTDA | $ 43,979,231 | $ 218,233,357 |
| Tax | $ 15,392,731 | $ 76,381,675 |
| EBDA | $ 28,586,500 | $ 141,851,682 |
| 7,795,778 | ||
| 9,863,794 | ||
| 17,659,572 | ||
| 46,293,928 |
| Data sources from Cowen May 2003 HIV report, UNAIDS.ORG, and other subject matter experts. | ||||||||||||
| 2013 | 2014 | 2015 | ||||||||||
| Total EU HIV+ population | ||||||||||||
| Untreated EU HIV+ | 419,172 | 409,320 | 397,120 | |||||||||
| HAART treated E.U. HIV+ | 340,827 | 348,200 | 357,080 | |||||||||
| DermaVir tretatment potetial | ||||||||||||
| Market share untreated (no HAART) | 1.00% | 6.00% | ||||||||||
| Market share treated (HAART) | 1.65% | 7.00% | ||||||||||
| HAART untreated DERMAVIR patients | 4,093 | 23,827 | ||||||||||
| HAART treated DERMAVIR patients | 5,745 | 24,996 | ||||||||||
| Total DermaVir patients | 9,839 | 48,823 | ||||||||||
| Total DermaVir treatments per year | 39,356 | 195,292 | ||||||||||
| Average yearly HAART treatment cost | $ 11,050 | |||||||||||
| Yearly DermaVir treatment cost | $ 6,600 | |||||||||||
| Cost of goods calculation | |||||||
| Lot number | quantity | concentration mg/ml) | filling volume (ml) | Cost/vial* (USD) | Storage cost/ vial | Total Cost**/ vial | |
| Plasmid DNA | CMA-DNA13 | 1 vial | 1 | 0.65 | $ 80.69 | $ 1.30 | $ 81.99 |
| PEIm | CMA-PEIm13 | 1 vial | 1.2 | 0.7 | $ 50.70 | $ 1.17 | $ 51.87 |
| dermaPrep | CMA-DP13 | 1 kit | 4 patches | $ 63.70 | $ 0.52 | $ 64.22 | |
| $ 195.09 | $ 198.08 | ||||||
| *Cost/vial : manufacturing cost/vial | |||||||
| **Cost/vial : manufacturing cost/vial+Storage costs | |||||||
| ALTHEA Plasmid DNA (lot #CMA-DNA13) - 50,000 vials | Cost (USD) | vials | |||||
| Feasibility study | $ 19,500 | ||||||
| Establishment of MCB | $ 23,400 | ||||||
| manufacturing equipment | $ 9,750 | ||||||
| Stability test (10/31/2013): | $ 19,500 | ||||||
| Caracterization of MCB (06/30/2013) : | $ 28,600 | ||||||
| In-process and final product testing (09/30/2013): | $ 58,500 | ||||||
| cGMP documentation (11/30/2013): | $ 234,000 | ||||||
| 20g GMP purified plasmid DNA bulk production (until 09/30/2014): | $ 3,445,000 | ||||||
| cGMP final fill and finish (until 09/30/2014): | $ 195,000 | ||||||
| HPLC and concentration determination(12/30/2013): | $ 1,430 | ||||||
| Summa 50,000 vials | $ 4,034,680 | 50,000 | |||||
| 1 vial: | $ 80.69 | ||||||
| Genetic ImmunityStorage of 50,000 vials of plasmid DNA | Cost (USD) | ||||||
| summa (including shipping from Althea) | $ 65,000 | ||||||
| 1 vial | $ 1.30 | ||||||
| PEIm (lot# CMA-PEIm13) 50,000 vials | Cost (USD) | ||||||
| Genetic Immunity: Synthesis | $ 2,340,000 | ||||||
| Elaiapharm: fill and finish | $ 195,000 | ||||||
| summa | $ 2,535,000 | 50,000 | |||||
| 1 vial | $ 50.70 | ||||||
| Genetic ImmunityStorage of 50,000 vials of PEIm | Cost (USD) | ||||||
| summa (including shipping from Elaiapharma) | $ 58,500 | 50,000 | |||||
| 1 vial | $ 1.17 | ||||||
| DermaPrep (50,000 kit) | Cost (USD) | ||||||
| 50,000 kits (containing 4 patches) | $ 3,185,000 | ||||||
| 50,000 kits summa | $ 3,185,000 | 50,000 | |||||
| 1 kit | $ 63.70 | ||||||
| Genetic ImmunityStorage of 50,000 kits of DermaPrep | Cost (USD) | ||||||
| summa | $ 26,000 | 50,000 | |||||
| 1 kit | $ 0.52 |
| Cost of treatment calculation | |||||
| Lot number | quantity | Total cost (USD) | Cost/treatment* (USD) | ||
| clinical cost | CMA-DNA13 | 50 sites | $ 1,625,000 | $ 32.50 | |
| marketing | CMA-PEIm13 | per sites | $ 7,150,000 | $ 143.00 | |
| pharmacovigilance/data management | CMA-DP13 | $ 234,000 | $ 4.68 | ||
| logistics (pDNA, PEIm, DermaPrep) | per dose | $ - | |||
| Patient insurance | per patient | $ 10.00 | |||
| CRO | CMA-DP13 | $ 3,022,500 | $ ��60.45 | ||
| total cost summary | $ 250.63 | ||||
| * calculated 50,000 treatment | |||||
| Clinical costs/logistics | Cost (USD) | sites | Logistics | ||
| site opening (with CRO) | $ 19,500 | pDNA shipping | cost | vials | |
| training of personnel for treatrment | $ 3,250 | vials to clinical sites | $ 97,500 | 50000 | |
| labor logistics | $ 3,250 | 1 vial | $ 1.95 | ||
| installation of clinical data manager software | $ 3,250 | ||||
| training of site personnel to handle the software | $ 3,250 | ||||
| travel | $ 13,000 | PEIm shipping | cost | vials | |
| setting up 24/7 support | $ 6,500 | 245 vials to Hamburg | $ 97,500 | 50000 | |
| 1 clinical site: | $ 32,500 | 50 | 1 vial | $ 1.95 | |
| for all clinical site: | $ 1,625,000 | ||||
| DermaPrep ship | cost (USD) | kits | |||
| Marketing | Cost (USD) | 50000 kits to clinical | $ 130,000 | 50000 | |
| patient information | $ 130,000 | 1 kit | $ 2.60 | ||
| site information | $ 13,000 | ||||
| marketing per clinical site | $ 143,000 | ||||
| for all clinical site: | $ 7,150,000 | 50 | |||
| Pharmacivigilance/Data management | Cost (USD) | ||||
| setting up pharmacovigilance system | $ 214,500 | ||||
| monitoring system | $ 19,500 | ||||
| for all clinical site: | $ 234,000 | ||||
| CRO (Contract Research Organisation) | Cost (USD) | ||||
| operation of pharmacovigilance and monitoring system | $ 21,450 | ||||
| data management and quality assurance | $ 19,500 | ||||
| managing regualtory affairs | $ 19,500 | ||||
| CRO cost per clinical site | $ 60,450 | ||||
| for all clinical site: | $ 3,022,500 | 50 |
| CMA | Cost per dose calculation | |||
| *Manufacturing cost/vial | ||||
| **Manufacturing cost/vial including storage and shipping costs calculated for one vial/kit | ||||
| Medium dose 0.4 mg pDNA | ||||
| Components | number of vials/treatment | Cost (USD)* | Cost** (USD) | |
| pDNA | 1 | $ 80.69 | $ 81.99 | |
| PEIm | 1 | $ 50.70 | $ 51.87 | |
| DermaPrep/kit | 1 | $ 63.70 | $ 64.22 | |
| TOTAL | $ 195.09 | $ 198.08 | ||