2021-10-14T10:29:19-05:00 2020-12-31 BDO USA LLP 100 PARK AVENUE NEW YORK NY 100175001 990 2020-01-01 134128413 GLOBAL ALLIANCE FOR TB DRUG DEVELOPMENT INC % ANGELA VANDERPLOEG GLOB 2122277540 40 WALL STREET 24TH FLOOR NEW YORK NY 10005 Angela Vanderploeg CFO 2122277540 2021-10-12 true Angela Vanderploeg XXX-XX-XXXX Paul Hammerschmidt P01384178 2128858000 2 2020 2022-09-23 18:48:47Z TB ALLIANCE DR MELVIN SPIGELMAN 40 WALL STREET 24TH FLOOR NEW YORK NY 10005 61267452 false X WWW.TBALLIANCE.ORG X 2000 DE TO ACCELERATE THE DISCOVERY & DEVELOPMENT OF NEW DRUGS TO FACILITATE THE CONTROL OF TUBERCULOSIS THROUGHOUT THE WORLD AND THE ACCESSIBILITY OF THESE DRUGS TO THE GLOBAL COMMUNITY. 9 8 51 8 0 0 68288037 60247338 0 0 106399584 952541 186278 67573 174873899 61267452 522335 336204 0 0 14649391 14748509 0 0 964462 54363353 46635676 69535079 61720389 105338820 -452937 189418881 191155661 24731091 26697735 164687790 164457926 X TB ALLIANCE IS A NOT-FOR-PROFIT ORGANIZATION DEDICATED TO THE DISCOVERY, DEVELOPMENT AND DELIVERY OF BETTER, FASTER-ACTING AND AFFORDABLE TUBERCULOSIS DRUGS THAT ARE AVAILABLE TO THOSE WHO NEED THEM. false false 51423326 63837 0 RESEARCH AND DEVELOPMENT - TB ALLIANCE IS A NOT-FOR-PROFIT PRODUCT DEVELOPMENT PARTNERSHIP (PDP), UNIQUELY POSITIONED TO LEVERAGE A GLOBAL NETWORK OF PUBLIC AND PRIVATE PARTNERS TO MOST EFFICIENTLY ADVANCE TB DRUG DEVELOPMENT. A PDP BUILDS PARTNERSHIPS BETWEEN THE PUBLIC, PRIVATE, ACADEMIC, AND PHILANTHROPIC SECTORS TO DRIVE THE DEVELOPMENT OF NEW PRODUCTS FOR UNDERSERVED MARKETS. PDPS RETAIN DIRECT MANAGEMENT OVERSIGHT OF THEIR PROJECTS, THOUGH MUCH OF THE LABORATORY AND CLINICAL WORK IS DONE THOUGH EXTERNAL RESEARCH FACILITIES AND CONTRACTORS. WE COMBINE THE RESEARCH AND DEVELOPMENT EXPERTISE OF OUR STAFF WITH THE SKILLS AND RESOURCES OF OUR PARTNERS TO HARNESS THE MOST PROMISING SCIENCE WHEREVER IT MAY EXIST AROUND THE WORLD. THIS MODEL MINIMIZES COSTS, INCLUDING OVERHEAD AND INVESTMENTS IN INFRASTRUCTURE, WHILE OPTIMIZING SCIENTIFIC CAPABILITY TO SPEED NEW TB DRUG DEVELOPMENT. OUR BUSINESS MODEL AND DIVERSE PARTNERSHIPS ALLOW TB ALLIANCE TO LEVERAGE ADDITIONAL PARTNER SERVICES FOR EVERY DOLLAR INVESTED IN THE TB ALLIANCE. NIX-TB - THE PHASE 3 NIX-TB TRIAL IS AN OPEN-LABEL, SINGLE ARM TRIAL THAT IS EVALUATING THE BPAL REGIMEN. NIX-TB PARTICIPANTS WITH EXTENSIVELY DRUG-RESISTANT TUBERCULOSIS (XDR-TB) AND TREATMENT-INTOLERANT OR NON RESPONSIVE MULTIDRUG-RESISTANT (MDR) TB WERE TREATED WITH BEDAQUILINE, PRETOMANID AND LINEZOLID OVER SIX MONTHS, EXTENDED TO NINE MONTHS IN TWO CASES, WITH THE INTENT TO CURE. NIX-TB ENROLLED 109 PARTICIPANTS IN THREE SITES IN SOUTH AFRICA. RESULTS PUBLISHED IN THE NEW ENGLAND JOURNAL OF MEDICINE SHOWED A 90% TREATMENT SUCCESS RATE. IN 2019, THE US FDA APPROVED PRETOMANID AS PART OF THIS REGIMEN. IN THE YEAR FOLLOWING US APPROVAL, BPAL HAS BEEN APPROVED IN THE EUROPEAN UNION AND INDIA AS WELL AS RECOMMENDED BY THE WORLD HEALTH ORGANIZATION FOR USE IN OPERATIONAL RESEARCH SETTINGS. In 2021, 24-month follow-up results continued to show high efficacy among trial participants, along with an abatement of side-effects associated with the drug linezolid. SIMPLICITB - SIMPLICITB IS EVALUATING THE EFFICACY, SAFETY AND TOLERABILITY OF A NOVEL AND POTENTIALLY SHORTER DRUG REGIMEN (BPAMZ) FOR PATIENTS WITH DRUG-SENSITIVE (DS) AND DRUG-RESISTANT(MDR) PULMONARY TUBERCULOSIS (SPECIFICALLY MULTIDRUG-RESISTANT TB AND MONO-RESISTANCE TO ISONIAZID OR RIFAMPICIN). THE BPAMZ REGIMEN IS COMPRISED OF FOUR DIFFERENT ANTIMICROBIALS: BEDAQUILINE (B), PRETOMANID (PA), MOXIFLOXACIN (M) AND PYRAZINAMIDE (Z). THE NEW DRUG REGIMEN IS ADMINISTERED FOR FOUR MONTHS TO PATIENTS WITH DS-TB, AND FOR SIX MONTHS TO PATIENTS WITH MDR-TB OR MONO-RESISTANCE TO RIFAMPICIN OR ISONIAZID. RESULTS IN THE DS-TB ARM WILL BE COMPARED TO A CONTROL GROUP OF THE STANDARD SIX-MONTH DRUG REGIMEN FOR DS-TB (HRZE). ZENIX - THE PHASE 3 ZENIX CLINICAL TRIAL IS EVALUATING THE BPAL REGIMEN TO TREAT EXTENSIVELY DRUG RESISTANT TUBERCULOSIS (XDR-TB) AND THOSE WITH PRE-XDR-TB AND MULTI-DRUG RESIDENT TB (MDR-TB) WHOSE PRIOR TREATMENT HAS FAILED OR WHO HAVE NOT TOLERATED THEIR TREATMENT. IT SEEKS TO OPTIMIZE LINEZOLID DOSING AS PART OF THE BPAL REGIMEN, EVALUATING BOTH THE LINEZOLID DOSE AND THE LINEZOLID DURATION. The top-line results of ZeNix were presented at IAS 2021, SHOWING that the effectiveness of the BPaL REGIMEN could be maintained with reduced dosing of linezolid. LIFT-TB (Leveraging Innovation for Faster Treatment of TB) This program, launched in 2020, seeks to increase treatment completion rates for drug-resistant TB through adoption and scale up of new regimens, beginnig with BPaL. It focuses on seven high-burden Southeast and Central Asian countries that shoulder approximately 1 in 5 OF THE GLOBAL TB cases. 4423135 272367 0 PUBLIC AFFAIRS AND POLICY - TB ALLIANCE MAINTAINS CRITICAL ALLIANCES WITH PUBLIC AND PRIVATE ORGANIZATIONS TO RAISE AWARENESS ABOUT TUBERCULOSIS ("TB") AND ADVOCATE FOR PUBLIC AND PRIVATE INVOLVEMENT IN RESEARCH FOR THE PUBLIC GOOD. SPECIFICALLY, TB ALLIANCE NEGOTIATES TERMS THAT SUPPORT THE DEVELOPMENT AND ACCESS OF NEW AFFORDABLE ANTI-TB DRUGS EQUITABLY FOR THOSE AREAS MOST IN NEED WHILE ENCOURAGING THE PRIVATE SECTOR ON THE DEVELOPMENT OF THESE MEDICINES. TB ALLIANCE CONTINUES TO PURSUE AN EXPLICIT COMMITMENT TO OUR "AAA MANDATE" - THAT ALL NEW PRODUCTS WILL BE ADOPTED, AVAILABLE AND AFFORDABLE TO THOSE WITH TB. 498136 0 0 BUSINESS DEVELOPMENT - TB ALLIANCE NEGOTIATES, IMPLEMENTS, AND MANAGES AGREEMENTS WITH PUBLIC AND PRIVATE ORGANIZATIONS WORLDWIDE AND DOES SO BY ADHERING TO SOUND BUSINESS PRACTICES WHILE ENSURING THE PUBLIC GOOD. SPECIFICALLY, TB ALLIANCE NEGOTIATES TERMS THAT SUPPORT THE DEVELOPMENT AND ACCESS OF NEW AFFORDABLE ANTI-TB DRUGS EQUITABLY TO THOSE AREAS MOST IN NEED WHILE ENCOURAGING THE PRIVATE SECTOR TO HELP DEVELOP NEW MEDICINES FOR TB INDICATIONS. 56344597 true true false false false false false false false false true false false false true true true false false true true true false false false false false false false true false false false false false false false false false false false false false false false false false true 90 0 true 51 true false false false false false false false false false false false false X 9 8 false false false false false false false true true false false true true true true true true true true false NY X ANGELA VANDERPLOEG 2122277540 40 WALL STREET 24TH FLOOR NEW YORK NY 10005 X DR MELVIN SPIGELMAN PRESIDENT/CEO 3.0 0.0 X X 963760 0 93329 Dr Nader Fotouhi Chief Scientific Officer 45.0 0.0 X 550024 0 103022 Dr Daniel Everitt Sr. Medical Officer & VP 45.0 0.0 X 488901 0 90370 Dr Eugene Sun Senior VP, R&D 45.0 0.0 X 487550 0 75913 Colleen Pero Secretary/CAO 45.0 0.0 X 455010 0 60712 Robert Lorette Sr. VP, Business Development 45.0 0.0 X 435171 0 78989 Angela Vanderploeg Treasurer/CFO 45.0 0.0 X 412395 0 90282 Sandeep Juneja Senior VP, Market Access 45.0 0.0 X 409849 0 89517 Dr Paul Bruinenberg Sr. Medical Officer 45.0 0.0 X 394093 0 74377 Willo Brock Senior VP, External Affairs 45.0 0.0 X 381828 0 73069 Kathleen Schostack VP, Program & Alliance Mgmt 45.0 0.0 X 376126 0 71702 Dr Bruce Carter Chairman 3.0 0.0 X X 0 0 0 DR MARIO RAVIGLIONE Vice Chair 3.0 0.0 X X 0 0 0 Jane Griffiths Director, as of 1/1/20 3.0 0.0 X 0 0 0 Jan Landberg Director 3.0 0.0 X 0 0 0 Ariel Pablos-Mendez Director 3.0 0.0 X 0 0 0 Nancy Miller Rich Director 3.0 0.0 X 0 0 0 Shalini Sharp Director 3.0 0.0 X 0 0 0 Mitchell Warren Director 3.0 0.0 X 0 0 0 5354707 0 901282 36 false true false PPD Global Limited GRANTA PARK CAMBRIDGE 0 UK CB21 6GQ Global CRO 5410522 Wuxi Apptec HongKong Limited 288 FUTE ZHONGLU SHANGHAI 0 CH 200131 Integrated R&D SVCS 5116096 Worldwide Clinical Trials 8609 Cross Park Drive AUSTIN TX 78754 Global CRO 2527935 University of Illinois 28395 Network Place CHICAGO IL 60673 Research Collab. 2174333 RTI International PO Box 900002 RALEIGH NC 27675 Integrated R&D SVCS 1850711 76 35293163 24954175 60247338 0 952541 952541 0 7585 7585 0 0 0 0 0 0 0 0 0 0 0 0 0 MISCELLANEOUS INCOME 900099 59988 59988 59988 61267452 1020114 X 0 0 336204 336204 0 3746893 2435068 995733 316092 0 8288728 6750755 1192535 345438 779804 636126 109397 34281 419651 355965 44470 19216 1513433 1163846 267824 81763 0 607415 544419 62996 88221 88221 0 0 0 10862127 10521051 341076 0 0 317281 48417 266152 2712 1193853 605559 547882 40412 0 1123710 824357 225206 74147 179304 135454 11042 32808 0 59320 31053 28267 0 0 195744 143640 39511 12593 223183 73421 149762 R&D PROJECT EXPENSES 31349113 31349113 PUBLIC AND MEDIA OUTREACH 323824 323824 DUES AND SUBSCRIPTIONS 112581 66325 41256 5000 61720389 56344597 4411330 964462 0 0 182678043 183366418 1716923 3797724 882162 104324 0 0 0 0 0 0 0 0 3455762 2966179 4835132 3973813 625849 861319 0 0 0 0 0 0 0 0 60142 59697 189418881 191155661 12118780 12587131 0 0 12606418 13887313 0 0 0 0 0 0 0 0 0 0 5893 223291 24731091 26697735 X 164687790 164457926 0 0 164687790 164457926 189418881 191155661 X -452937 211935 11138 X false true X true true true X 52895919 57593669 62252482 68288037 60247338 301277445 0 0 52895919 57593669 62252482 68288037 60247338 301277445 134120362 167157083 137450 357901 1019722 1399584 960126 3874783 0 0 54928 11286 186278 59988 312480 305464708 0.54722 0.49408 X RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 3689314 2880767 808547 678041 625269 52772 467777 467777 0 861319 0 DEFERRED RENT 223291 223291 X 61479387 211935 211935 61267452 61267452 61720389 61720389 61720389 PART X, LINE 2: UNDER FINANCIAL ACCOUNTING STANDARDS BOARD (FASB) ACCOUNTING STANDARDS CODIFICATION ("ASC") 740, "INCOME TAXES", AN ORGANIZATION MUST RECOGNIZE THE TAX BENEFIT ASSOCIATED WITH TAX POSITIONS TAKEN FOR TAX RETURN PURPOSES WHEN IT IS MORE LIKELY THAN NOT THE POSITION WILL BE SUSTAINED UPON EXAMINATION BY A TAXING AUTHORITY. GLOBAL ALLIANCE FOR TB DRUG DEVELOPMENT, INC. DOES NOT BELIEVE IT HAS TAKEN ANY MATERIAL UNCERTAIN TAX POSITIONS AND, ACCORDINGLY, IT HAS NOT RECORDED ANY LIABILITY FOR UNRECOGNIZED TAX BENEFITS. THE ORGANIZATION HAS FILED FOR AND RECEIVED INCOME TAX EXEMPTIONS IN THE JURISDICTIONS WHERE IT IS REQUIRED TO DO SO. ADDITIONALLY, THE ORGANIZATION HAS FILED IRS FORM 990 INFORMATION RETURNS, AS REQUIRED, AND ALL OTHER APPLICABLE RETURNS IN JURISDICTIONS WHERE SO REQUIRED. FOR THE YEAR ENDED DECEMBER 31, 2020, THERE WAS NO INTEREST OR PENALTIES RECORDED OR INCLUDED IN THE STATEMENT OF ACTIVITIES. THE ORGANIZATION IS SUBJECT TO ROUTINE AUDITS BY A TAXING AUTHORITY. true East Asia and the Pacific Program Services ADMIN EXPENSES 2500 East Asia and the Pacific Program Services Consulting Services 1838088 East Asia and the Pacific Grantmaking 86692 East Asia and the Pacific Program Services R&D Research 7664989 Europe (Including Iceland and Greenland) Program Services ADMIN EXPENSES 72384 Europe (Including Iceland and Greenland) 5 Program Services Consulting Services 1902990 Europe (Including Iceland and Greenland) Grantmaking 45000 Europe (Including Iceland and Greenland) Program Services R&D Research 8763973 Middle East and North Africa Program Services Admin Expenses 5504 North America Program Services Admin Expenses 600 North America Program Services Consulting Services 60058 Russia and the Newly Independent States 3 Program Services Consulting Services 22366 Russia and the Newly Independent States Grantmaking 3000 Russia and the Newly Independent States Program Services R&D Research 68 South America 2 Program Services Consulting Services 101427 South America Grantmaking 26646 South Asia 1 Program Services Consulting Services 74011 South Asia Program Services R&D Research 736486 Sub-Saharan Africa Program Services Admin Expenses 112274 Sub-Saharan Africa 11 Program Services Consulting Services 288787 Sub-Saharan Africa Grantmaking 174866 Sub-Saharan Africa Program Services R&D Research 377497 Sub-Saharan Africa 1 6 Program Services Salary Expense 677635 11 1 17 1 28 20670296 2367545 23037841 Sub-Saharan Africa COMM. ENGAGE 109005 WIRE East Asia and the Pacific comm. engage 63237 WIRE Europe (Including Iceland and Greenland) comm. engage 45000 WIRE South America COMM. ENGAGE 26646 WIRE East Asia and the Pacific COMM. ENGAGE 21954 WIRE Sub-Saharan Africa COMM. ENGAGE 19439 WIRE Sub-Saharan Africa COMM. ENGAGE 16190 WIRE Sub-Saharan Africa COMM. ENGAGE 14738 WIRE Sub-Saharan Africa COMM. ENGAGE 8894 WIRE 9 SUB-SAHARAN - WITS-Health Consortium Russia and the Newly Independent States 2 1500 Wire Sub-Saharan Africa 1 600 WIRE false false false false false false PART I, LINE 2: The grantee is required to provide the organization with an itemized accounting of expenditures for the Project and a report on the progress of the Project on a schedule specified in the agreement. This requirement is outlined in the signed agreement between both parties. X X X X X false false false false false false false true false DR MELVIN SPIGELMAN PRESIDENT/CEO 574580 0 389180 0 0 0 57000 0 36329 0 1057089 0 0 0 Colleen Pero Secretary/CAO 321204 0 133806 0 0 0 39567 0 21145 0 515722 0 0 0 Angela Vanderploeg Treasurer/CFO 288133 0 124262 0 0 0 39700 0 50582 0 502677 0 0 0 Dr Eugene Sun Senior VP, R&D 395459 0 92091 0 0 0 43781 0 32132 0 563463 0 0 0 Dr Nader Fotouhi Chief Scientific Officer 385253 0 164771 0 0 0 50203 0 52819 0 653046 0 0 0 Willo Brock Senior VP, External Affairs 267712 0 114116 0 0 0 36752 0 36317 0 454897 0 0 0 Dr Daniel Everitt Sr. Medical Officer & VP 371319 0 117582 0 0 0 40821 0 49549 0 579271 0 0 0 Robert Lorette Sr. VP, Business Development 306479 0 128692 0 0 0 43020 0 35969 0 514160 0 0 0 Sandeep Juneja Senior VP, Market Access 287183 0 122666 0 0 0 38599 0 50918 0 499366 0 0 0 Dr Paul Bruinenberg Sr. Medical Officer 313931 0 80162 0 0 0 38006 0 36371 0 468470 0 0 0 Kathleen Schostack VP, Program & Alliance Mgmt 281109 0 95017 0 0 0 35742 0 35960 0 447828 0 0 0 PART I, LINE 7: MERIT BONUSES ARE PAID TO STAFF MEMBERS BASED ON ANNUAL PERFORMANCE. SEE SCHEDULE O RESPONSE TO FORM 990, PART VI, SECTION B, LINES 15A AND 15B FOR ADDITIONAL DETAIL. FORM 990, PART VI, SECTION B, LINE 11B: FORM 990 WAS PREPARED BY A NATIONALLY RECOGNIZED ACCOUNTING FIRM IN CONJUNCTION WITH THE ORGANIZATION'S FINANCIAL DEPARTMENT. DRAFT FORM 990 WAS REVIEWED BY THE ORGANIZATION'S FINANCE DEPARTMENT AND SENIOR MANAGEMENT, AND THEN PROVIDED TO ALL MEMBERS OF THE BOARD OF DIRECTORS IN DRAFT VIA ELECTRONIC MAIL, WITH AN OPPORTUNITY FOR THEM TO COMMENT OR MAKE INQUIRY BEFORE IT WAS FILED WITH THE INTERNAL REVENUE SERVICE. FORM 990, PART VI, SECTION B, LINE 12C: THE ORGANIZATION'S CONFLICT POLICY IS DISTRIBUTED TO OFFICERS AND DIRECTORS ANNUALLY ALONG WITH A QUESTIONNAIRE THAT IS COMPLETED BY ALL OFFICERS AND DIRECTORS IN WHICH THEY ARE ASKED TO DISCLOSE INFORMATION REGARDING ACTUAL OR POTENTIAL CONFLICTS. THESE QUESTIONNAIRES ARE COLLECTED AND REVIEWED ANNUALLY TO ENSURE COMPLIANCE WITH THE CONFLICT POLICY. THE POLICY ITSELF ALSO REQUIRES ANY DIRECTOR OR OFFICER TO PROMPTLY DISCLOSE ANY CONFLICT OF INTEREST. INTERESTED DIRECTORS AND OFFICERS ARE REQUIRED TO RECUSE THEMSELVES FROM ANY DECISION ON MATTERS IN WHICH THEY HAVE AN INTEREST, AND SUCH RECUSAL IS NOTED IN THE MINUTES. FORM 990, PART VI, SECTION B, LINES 15A AND 15B: THE COMPENSATION COMMITTEE, WHICH CONSISTS OF THREE INDEPENDENT BOARD MEMBERS, ANNUALLY REVIEWS THE CEO AND OFFICERS COMPENSATION IN CONJUNCTION WITH AN EVALUATION OF ORGANIZATIONAL PERFORMANCE. THE COMMITTEE RECOMMENDS ADJUSTMENTS IN COMPENSATION TO THE FULL BOARD FOR REVIEW AND APPROVAL, WITHIN THE CONTEXT OF AN AGREED UPON COMPETITIVE POSITION. THE COMPETITIVENESS OF COMPENSATION IS PERIODICALLY BENCHMARKED USING INDEPENDENT SALARY SURVEY DATA FROM THE NOT-FOR-PROFIT AND FOR-PROFIT INDUSTRY. THE COMPENSATION COMMITTEE DOCUMENTATION INCLUDES THE PERFORMANCE ASSESSMENT, COMPARABLE DATA AND THE SOURCE OF THIS DATA, AND THE RECOMMENDED ADJUSTMENTS. THE MINUTES OF THE FULL BOARD INCLUDE DOCUMENTATION OF THE APPROVED DECISIONS. THE MINUTES OF THE BOARD AND COMMITTEE ARE PREPARED BEFORE THE LATER OF THE NEXT MEETING OR 60 DAYS AFTER THE FINAL DECISION OF THE BOARD AND THE COMMITTEE. FORM 990, PART VI, SECTION C, LINE 19: THE ORGANIZATION MAKES ITS GOVERNING DOCUMENTS, CONFLICT OF INTEREST POLICY, AND FINANCIAL STATEMENTS AVAILABLE TO THE PUBLIC UPON REQUEST. FORM 990, PART IX, LINE 11G: PROFESSIONAL SERVICES AND AGREEMENTS INCLUDE INDIVIDUAL CONSULTANTS WHO ARE CONTRIBUTING THEIR SPECIFIC EXPERTISE RELATED TO OUR CLINICAL TRIALS AND OTHER EARLY STAGE AND PRECLINICAL DISCOVERY WORK. EXPERTISE IN SUCH AREAS AS PHARMACOVIGILANCE, NON-GLP BIOANALYSIS, ANALYTICAL EVALUATION OF DRUG STABILITY AND PROGRAM MANAGEMENT ARE SOME OF THE SERVICES REQUIRED IN ORDER TO COMPLETE OUR SCIENTIFIC RESEARCH AND DEVELOPMENT. THESE CONSULTANTS ARE MANAGED BY OUR STAFF, WHO COORDINATE THE WORK NECESSARY TO BE COMPLETED AMONG ALL OUTSIDE PARTIES. FORM 990, PART XI, LINE 9: FOREIGN TRANSLATION GAIN....$ 11,138. FORM 990 PART IX LINE 11G DESCRIPTION:PROFESSIONAL SVCS & AGREEMENTS TOTAL FEES:10862127