Economic Evaluation Report June 30, 2020

for Insulina

1. EXECUTIVE SUMMARY (2022 prices)

Total Capital Investment 281,450,000 $

Capital Investment Charged to This Project 281,450,000 $
Operating Cost 121,266,000 $/yr
Revenues 180,352,000 $/yr
Cost Basis Annual Rate 1,804 kg MP/yr
Unit Production Cost 67,238.37 $/kg MP
Unit Production Revenue 100,000.00 $/kg MP
Gross Margin 32.76 %
Return On Investment 19.13 %
Payback Time 5.23 years
IRR (After Taxes) 19.77 %
NPV (at 7.0% Interest) 155,623,000 $
MP = Flow of Component 'Insulin Crystal' in Stream 'Product'

- Page 1 -
2. MAJOR EQUIPMENT SPECIFICATION AND FOB COST (2022 prices)

Quantity/
Standby/ Name Description Unit Cost ($) Cost ($)
Staggered
1/0/0 BT-101 Blending Tank 493,000 493,000
Vessel Volume = 41176.86 L
1/0/0 ST-101 Heat Sterilizer 734,000 734,000
Rated Throughput = 12.35 m3/h
1/0/0 MX-101 Mixer 0 0
Size/Capacity = 1392.93 kg/h
1/0/0 G-101 Centrifugal Compressor 196,000 196,000
Power = 102.47 kW
1/0/0 AF-101 Air Filter 13,000 13,000
Rated Throughput = 0.35 m3/s
1/0/0 AF-102 Air Filter 13,000 13,000
Rated Throughput = 0.35 m3/s
1/0/0 FR-101 Fermentor 1,837,000 1,837,000
Vessel Volume = 50000.00 L
3/0/0 DS-101 Disk-Stack Centrifuge 689,000 2,067,000
Throughput = 3.95 L/min
1/0/0 HG-101 Homogenizer 102,000 102,000
Rated Throughput = 7.69 m3/h
2/0/0 DF-101 Diafilter 187,000 374,000
Membrane Area = 77.79 m2
1/0/0 DE-101 Dead-End Filter 57,000 57,000
Filter Area = 10.00 m2
2/0/0 VT-101 Vertical-On-Legs Tank 61,000 122,000
Vessel Volume = 20782.81 L
1/0/0 V-101 Stirred Reactor 999,000 999,000
Vessel Volume = 12277.69 L
1/0/0 CSP-101 Component Splitter 80,000 80,000
Size/Capacity = 6612.31 kg/h
1/0/0 V-102 Stirred Reactor 1,049,000 1,049,000
Vessel Volume = 15552.56 L
2/0/0 V-104 Stirred Reactor 1,113,000 2,226,000
Vessel Volume = 20140.25 L
6/0/0 DF-102 Diafilter 178,000 1,068,000
Membrane Area = 69.23 m2
1/0/0 DF-103 Diafilter 93,000 93,000
Membrane Area = 20.97 m2
1/0/0 C-105 GFL Chromatography Column 599,000 599,000
Column Volume = 174.15 L
1/0/0 BCF-101 Basket Centrifuge 179,000 179,000
Filter Area = 0.41 m2
1/0/0 FDR-101 Freeze Dryer 141,000 141,000
Sublimation Capacity = 5.11 kg
3/0/0 C-101 PBA Chromatography Column 738,000 2,214,000
Column Volume = 344.62 L
2/0/0 C-102 PBA Chromatography Column 750,000 1,500,000

- Page 2 -
 Column Volume = 358.28 L
1/0/0 C-103 PBA Chromatography Column 681,000 681,000
Column Volume = 276.87 L
1/0/0 C-104 PBA Chromatography Column 677,000 677,000
Column Volume = 271.75 L
1/0/0 BT-102 Blending Tank 390,000 390,000
Vessel Volume = 17097.45 L
1/0/0 BT-103 Blending Tank 333,000 333,000
Vessel Volume = 4745.26 L
1/0/0 V-106 Stirred Reactor 593,000 593,000
Vessel Volume = 198.34 L
1/0/0 V-105 Stirred Reactor 926,000 926,000
Vessel Volume = 5108.69 L
1/0/0 DF-105 Diafilter 101,000 101,000
Membrane Area = 24.11 m2
1/0/0 DF-104 Diafilter 73,000 73,000
Membrane Area = 13.99 m2
1/0/0 V-103 Stirred Reactor 1,013,000 1,013,000
Vessel Volume = 9839.71 L
Unlisted Equipment 5,236,000
TOTAL 26,179,000

- Page 3 -
3. FIXED CAPITAL ESTIMATE SUMMARY (2022 prices in $)

3A. Total Plant Direct Cost (TPDC) (physical cost)

1. Equipment Purchase Cost 26,179,000
2. Installation 14,810,000
3. Process Piping 9,163,000
4. Instrumentation 13,089,000
5. Insulation 785,000
6. Electrical 2,618,000
7. Buildings 39,268,000
8. Yard Improvement 3,927,000
9. Auxiliary Facilities 15,707,000
TPDC 125,546,000

3B. Total Plant Indirect Cost (TPIC)

10. Engineering 31,386,000
11. Construction 43,941,000
TPIC 75,327,000

3C. Total Plant Cost (TPC = TPDC+TPIC)

TPC 200,873,000

3D. Contractor's Fee & Contingency (CFC)

12. Contractor's Fee 10,044,000
13. Contingency 20,087,000
CFC = 12+13 30,131,000

3E. Direct Fixed Capital Cost (DFC = TPC+CFC)

DFC 231,004,000

- Page 4 -
4. LABOR COST - PROCESS SUMMARY

Unit Cost Annual Amount Annual Cost

Labor Type %
($/h) (h) ($)
Operator 69.00 117,604 8,114,671 100.00
TOTAL 117,604 8,114,671 100.00

- Page 5 -
5. MATERIALS COST - PROCESS SUMMARY

Unit Cost Annual Annual Cost

Bulk Material %
($) Amount ($)
Glucose 0.600 782,238 kg 469,343 1.56
Salts 1.000 71,428 kg 71,428 0.24
Water 0.050 9,700,108 kg 485,005 1.61
H3PO4 (5% w/w) 1.000 3,962,971 kg 3,962,971 13.14
NaOH (0.5 M) 0.500 3,826,656 kg 1,913,328 6.34
WFI 0.100 51,872,186 kg 5,187,219 17.20
Ammonia 0.700 81,553 kg 57,087 0.19
Air 0.000 3,930,093 kg 0 0.00
EDTA 18.500 10,418 kg 192,734 0.64
TRIS Base 6.000 43,162 kg 258,974 0.86
Triton-X-100 1.500 3,035 kg 4,553 0.02
MrEtOH 3.000 98,660 kg 295,980 0.98
Urea 1.520 3,058,145 kg 4,648,381 15.41
CNBr 11.000 15,268 kg 167,953 0.56
Formic acid 1.600 1,751,525 kg 2,802,441 9.29
Guanidine HCl 2.150 805,593 kg 1,732,025 5.74
Na2O6S4 0.600 24,159 kg 14,495 0.05
NH4HCO3 1.000 5,551 kg 5,551 0.02
Sodium sulfite 0.400 48,318 kg 19,327 0.06
Sodium Chloride 1.230 776,018 kg 954,502 3.17
Acetic-Acid 2.500 975,739 kg 2,439,347 8.09
Sodium Hydroxid 3.500 137,269 kg 480,441 1.59
Enzymes 500,000.000 3 kg 1,691,128 5.61
Acetonitrile 3.000 764,736 kg 2,294,209 7.61
Ammonium Acetat 15.000 181 kg 2,718 0.01
Zinc Chloride 12.000 320 kg 3,840 0.01
TOTAL 30,154,979 100.00

NOTE: Bulk material consumption amount includes material used as:

- Raw Material
- Cleaning Agent
- Heat Transfer Agent (if utilities are included in the operating cost)

- Page 6 -
6. VARIOUS CONSUMABLES COST (2022 prices) - PROCESS SUMMARY

Units Cost Annual Annual Cost

Consumable %
($) Amount ($)
Dft DEF Cartridge 500.000 160 item 80,000 0.23
UF Membrane (Biotech) 800.000 3,895 m2 3,115,793 8.84
INX Biotech Resin 1,500.000 12,660 L 18,989,706 53.88
HIC Biotech Resin 2,000.000 4,299 L 8,598,638 24.40
Gel Filtration Resin 800.000 5,573 L 4,458,354 12.65
TOTAL 35,242,491 100.00

- Page 7 -
7. WASTE TREATMENT/DISPOSAL COST (2022 prices) - PROCESS
SUMMARY
Unit Cost Annual Annual Cost
Waste Category %
($) Amount ($)
Solid Waste 0 0.00
Aqueous Liquid 5,889,948 76.21
Liq Waste 4 0.150 3,073,741 kg 461,061 5.97
Liq Waste 5 0.005 4,269 kg 21 0.00
Liq waste 1 0.005 5,074,178 kg 25,371 0.33
Liq Waste 2 0.005 2,257,936 kg 11,290 0.15
Liq Waste 3 0.005 464,646 kg 2,323 0.03
Liq Waste 6 0.150 2,008,131 kg 301,220 3.90
Liq Waste 7 0.150 14,283,396 kg 2,142,509 27.72
Liq Waste 8 0.150 8,058,561 kg 1,208,784 15.64
Liq Waste 9 0.150 8,863,997 kg 1,329,600 17.20
Liq Waste 10 0.005 1,222,051 kg 6,110 0.08
Liq Waste 11 0.005 2,905,024 kg 14,525 0.19
Liq Waste 13 0.150 2,106,214 kg 315,932 4.09
Liq Waste 14 0.150 257,979 kg 38,697 0.50
Liq Waste 15 0.005 6,464,707 kg 32,324 0.42
Liq Waste 17 0.005 36,273 kg 181 0.00
Organic Liquid 0 0.00
Emissions 1,838,352 23.79
S-127 1.000 1,838,352 kg 1,838,352 23.79
TOTAL 7,728,300 100.00

Unit
Annual Annual Disposal
Consumable Disposal %
Amount Cost ($)
Cost ($)
HIC Biotech Resin 80.000 4,299 L 344,000 100.00
TOTAL 344,000 100.00

- Page 8 -
8. UTILITIES COST (2022 prices) - PROCESS SUMMARY

Unit Cost Annual Ref. Annual Cost

Utility %
($) Amount Units ($)
Std Power 0.100 1,461,506 kW-h 146,151 72.06
NaCl Brine 0.250 22,060 MT 5,515 2.72
Steam 0.280 731 MT 205 0.10
Glycol 0.190 67,615 MT 12,847 6.33
Cooling Water 0.025 48,457 MT 1,211 0.60
Chilled Water 0.175 210,813 MT 36,892 18.19
TOTAL 202,821 100.00

- Page 9 -
9. ANNUAL OPERATING COST (2022 prices) - PROCESS SUMMARY

Cost Item $ %
Raw Materials 30,155,000 24.87
Labor-Dependent 8,115,000 6.69
Facility-Dependent 37,450,000 30.88
Laboratory/QC/QA 2,029,000 1.67
Consumables 35,242,000 29.06
Waste Treatment/Disposal 8,072,000 6.66
Utilities 203,000 0.17
Transportation 0 0.00
Miscellaneous 0 0.00
Advertising/Selling 0 0.00
Running Royalties 0 0.00
Failed Product Disposal 0 0.00
TOTAL 121,266,000 100.00

- Page 10 -
10. PROFITABILITY ANALYSIS (2022 prices)

A. Direct Fixed Capital 231,004,000 $

B. Working Capital 4,245,000 $
C. Startup Cost 46,201,000 $
D. Up-Front R&D 0$
E. Up-Front Royalties 0$
F. Total Investment (A+B+C+D+E) 281,450,000 $
G. Investment Charged to This Project 281,450,000 $

H. Revenue Rates
Product (Main Revenue) 1,804 kg /yr

I. Revenue Price
Product (Main Revenue) 99,977.78 $/kg

J. Revenues
Product (Main Revenue) 180,352,000 $/yr
Total Revenues 180,352,000 $/yr

K. Annual Operating Cost (AOC)

AOC 121,266,000 $/yr

L. Unit Production Cost /Revenue

Unit Production Cost 67,238.37 $/kg MP
Unit Production Revenue 100,000.00 $/kg MP

M. Gross Profit (J-K) 59,086,000 $/yr

N. Taxes (40%) 23,634,000 $/yr
O. Net Profit (M-N + Depreciation) 53,840,000 $/yr

Gross Margin 32.76 %

Return On Investment 19.13 %
Payback Time 5.23 years
MP = Flow of Component 'Insulin Crystal' in Stream 'Product'

- Page 11 -
- Page 12 -