MAPS Bulletin Winter 2018: Vol. 28, No. 3
It’s my pleasure and responsibility to present the Annual Report for the finances of the Multidisciplinary Association for Psychedelic Studies (MAPS). Each year, MAPS, a 501(c)(3) non-profit organization, presents its year-end consolidated financial report with details about our income and its sources, as well as our expenses and how they are allocated and projects prioritized. We do this as a commitment to transparency and an invitation to dialogue.
This report describes our most recently completed Fiscal Year from June 1, 2017 to May 31, 2018 (FY18) and consolidates financial information from MAPS, MAPS Inc. (MAPS’ Canadian non-profit), and MAPS’ wholly-owned for-profit subsidiaries the MAPS Public Benefit Corporation (MPBC) and MAPS Europe BV.
MPBC was created in December 2015 to conduct MAPS’ clinical research and eventually to market MDMA as an FDA-approved prescription medicine for PTSD, an outcome we currently anticipate will take place in 2021 (additional information can be found at mapsbcorp.com). MAPS Europe BV was created in February 2018 to conduct MAPS’ clinical research and eventually to market MDMA in Europe with approval by the European Medicines Agency (EMA), estimated in 2022. MAPS’ top priority project is working to obtain worldwide approval for the legal prescription use of MDMA with approvals for indications beyond PTSD as funding permits.
MAPS’ FY18 Annual Report demonstrates our efforts to strategically leverage the resources that MAPS supporters have so generously empowered us to use to transform psychedelics and marijuana into approved prescription medicines. Medicalization of psychedelics and marijuana is an essential part of our larger mission to mainstream these substances for a wide range of beneficial uses for a diverse and inclusive population of people.
MAPS’ annual financial reports, audits, and IRS 990 forms can be found at maps.org/about/fiscal. If you have any questions or comments about anything in this financial report, or would like to become more involved, we invite you to contact askMAPS@maps.org.
MAPS needs your help to expedite legal access for many millions of people in the US and around the world to the healing and spiritual potentials of psychedelics and marijuana. You can donate any time at maps.org/donate.
Income in FY18 was the highest in MAPS’ entire 32-year history. MAPS’ net revenue in Fiscal Year 2018 (June 1, 2017 – May 31, 2018), totaled $19,066,615 from 3,433 donors, as well as events, sales, and investments. This total includes $18,279,144 in contributed revenue, $254,082 from events/sales, $742,213 from a grant from the Colorado Department of Public Health and Environment (CDPHE) for our marijuana/PTSD study, $563,743 from Fiscal Sponsorship income, and $243,680 in restricted donations and earned income by MAPS’ Zendo Project providing harm reduction services at festivals and offering an advanced training program.
Expenses in FY19 totaled $7,774,908, also the largest in MAPS’ entire history. FY18 expenses were over $1.8 million more than FY17, over $3.3 million more than FY16, and over $4.5 million more than in FY15. The dramatic increase in expenses over the last four years is primarily a result of MAPS’ transition from Phase 2 to Phase 3 studies of MDMA-assisted psychotherapy for PTSD, along with the expansion of our MDMA program to include several Phase 2 studies of MDMA-assisted psychotherapy for PTSD, social anxiety and end-of-life anxiety, and a study for smoked marijuana for symptoms of PTSD. In FY17, MAPS increased its net assets by $230,450 and in FY18 MAPS increased its net assets by $11,291,707.
For historical information on overall annual income, expenses, and net assets, see Chart 1. Chart 1A presents historical information and projections for MAPS consolidated expenses for the MDMA drug development program for FDA only and for FDA + EMA. Charts 2 and 4 present detailed information on FY18, with Chart 3 projecting annual income, expenses, and net assets for FY19. Total amounts of restricted funds are listed in Chart 5 on a by project basis. Chart 6 is a detailed discussion of MAPS’ expenses for FY18 on a project by project basis. With Charts 7 and 8 show long-term cost estimates for developing Phase 3 MDMA-assisted psychotherapy for PTSD into a legal prescription treatment by FDA and EMA respectively.
The largest variable that impacts expenses for FDA and EMA approval is the number of subjects we’ll need to enroll in Phase 3 trials. This depends on the magnitude of the treatment effect with the larger the effect size, the fewer number of subjects needed for statistical significance. We anticipate that we will be able to make MDMA-assisted psychotherapy for PTSD into a legal prescription treatment in Europe through the EMA for approximately one-third the cost of the FDA program. This is because EMA will consider the data collected in the FDA studies as confirmatory data to support approval, requiring only one additional Phase 3 study while FDA is requiring two Phase 3 studies, along with other safety data.
MAPS has achieved an enormous success in fully funding projected expenses for FDA approval, but there are still funding gaps anticipated in FY19 including $1.15 million in operational expenses (with $921,000 left to raise) and funding for EMA Phase 3 research (estimated to require $9 million, of which we have raised roughly $900,000). Fortunately, we now have a clear path to FDA approval for the prescription use of MDMA-assisted psychotherapy for PTSD so our cost-estimates are becoming more precise. Nevertheless, we won’t know how many subjects we are going to need for Phase 3 until the interim analysis of our first Phase 3 study, which we anticipate will take place in mid-2019.
FOR FISCAL YEAR 2017–18
The search for funding for Phase 3 trials of MDMA-assisted psychotherapy for PTSD for FDA approval was a major priority in FY18. MAPS had projected contributed revenue of $6.1 million for FY18, but received an additional $12.1 million above what was projected, for a total of $18.2 million in contributed revenue. This windfall of support allowed MAPS to fully fund anticipated expenses for FDA Phase 3 MDMA/PTSD research, a staggering $26.7 million project.
Marked increases in FY18 compared to FY17 were seen in individual contributions (526%), foundation contributions (420%), fiscal sponsorship income (88%), and harm reduction income (88%). Revenue from events and sales decreased by 76%, which can be attributed to Psychedelic Science 2017, the largest psychedelic science conference ever convened, taking place in FY17. In FY18, a loss of -$719,080 was realized in investments and other income, largely attributed to liquidation of cryptocurrency and the rapidly fluctuating value.
Major factors in overall revenue for FY18 include the outstanding support from the cryptocurrency community, especially the Pineapple Fund and several anonymous donors.
For an in-depth discussion of funding sources, see the Sources of Revenue section, and the article by Pine of the Pinea
pple Fund on pages 36 –37. In FY18, MAPS raised $15,278,393 for research of which $14,500,365 was raised for MDMA-related research and $778,028 was raised for marijuana and other research projects.
Major support totaling $14,422,145 was received for MAPS’ Phase 3 MDMA-assisted psychotherapy studies. This includes $14,395,477 for Phase 3 General Support which has been used to design the Phase 3 protocol and prepare submissions to FDA, prepare sites for the trials, and recruit staff; and $26,668 towards the production of the GMP MDMA study drug for the research. MAPS also received $78,220 for other MDMA research projects.
For research other than with MDMA, MAPS raised $727,858 for our study of marijuana for treating PTSD in 76 US veterans, funded by a $2.15 million cost reimbursable grant
from the Colorado Department of Public Health and Environment (CDPHE), the income of which will be recognized monthly as received over the next two years.
MAPS received additional revenue of $762,288 from its educational initiatives. This includes $243,680 from psychedelic harm reduction crowd funding, services and training, $254,082 from events and sales, and $563,743 in Fiscal Sponsorships (see Notes 1 and 2).
The balance of MAPS’ funds raised in FY17, in the amount of $2,928,417, which included $274,718 from educational events, trainings, and harm reduction initiatives, was designated for unrestricted use.
SOURCES OF REVENUE
IN FISCAL YEAR 2017–18
About 94% of net revenue was contributed by 3,433 individual donors and family foundations. In FY18, number of donors increased by 44%, and there was a 482% increase in amount raised compared to FY17.
The most obvious source of this major windfall was the Pineapple Fund, which contributed $1 million worth of Bitcoin to MAPS in December 2017. This inspired an additional $1 million worth of Bitcoin from an anonymous donor. In the same month, MAPS also received a donation of LUN tokens worth $769,203. The Pineapple Fund then offered a $4 million matching grant for FDA Phase 3, for the period of January 10 to March 10, 2018, which inspired yet another $1 million donation worth of Bitcoin from James Evans. MAPS completed the match, raising over $8 million for Phase 3. The Pineapple Fund also included roughly $339,118 in unrestricted money to cover volatility and fees during the transfer and liquidation of the donated Bitcoin. MAPS raised approximately $2.7 in cryptocurrency donations above and beyond the $8 million raised from the Pineapple Fund matching grant. You can learn more about the philanthropist behind the Pineapple Fund in their article on pages36 –37. Other notable sources of Phase 3 funding in FY18 came from The Sarlo Foundation ($1,000,001), Dr. Bronner’s ($800,000), Britt Selvitelle ($1,000,000), the RiverStyx Foundation ($800,000), and the efforts of Clay Rockefeller and Rebecca Lambert, in honor of their late father, Richard Rockefeller. At the very end of FY18, Clay, Rebecca, and their cousins collectively donated $500,000 to complete funding for FDA Phase 3.
MAPS had the most successful Year-End Fundraising and Zendo Project Crowdfunding Campaigns to date in FY18. Year-End Fundraising brought in $460,246 from over 800 donors in 28 countries. Matching grants were provided by three anonymous donors ($30,000), Justin Rosenstein ($15,000), The Sarlo Foundation ($10,000), and Bonnie Brunet & Martin Rist ($5,000).
From July through September 2017, 374 donors raised over $102,000 for the Zendo Project. This campaign raised twice as much as the campaign in 2016 and raised more than any Zendo fundraising campaign to date. Cody Swift of the RiverStyx Foundation generously gave $30,000 towards the campaign and an anonymous donor offered a $20,000 matching grant.
In FY18, MAPS hosted or helped organize seven fundraising event and six cultivation events which raised $226,411. These events are often in the format of a small to medium dinner or reception and offer opportunities to build relationships with our core supporters, connect with new supporters, and establish new audiences in new places. These events included the CryptoCruise ($15,250); Legalizing Psychedelic Medicine in NYC ($57,842), Atlanta, GA ($10,215), and Boulder, CO
($22,375); a Washington D.C. Dinner ($2,590); Exploring Psychedelic Medicine in Fort Collins, CO ($7,514); ArcView Dinner in Los Angeles ($35,828); and Psychedelic Possibilities Benefit in Austin, TX ($35,047).
Although there was a decrease in number of donors between FY16 and FY17, FY18 saw a considerable increase in donors to 3,433 (44% increase) with a renewal rate of 35%. This can be partially attributed to the aftermath of Psychedelic Science in April 2017. The conference drew many first-time contacts into MAPS’ database, with a fair portion being converted into donors in the following fiscal year. The conference also re-engaged lapsed donors who hadn’t given in some time.
Another reason for the increase in donors is due to ever-growing grassroots campaigns, which typically bring in new donors at a rate of 50-60%.
Monthly donors are some of MAPS’ most dedicated supporters. It’s noteworthy that monthly donors – people who set up automatic donations on a monthly basis – increased from 181 in FY17 to 232 in FY18 contributing $54,805 in revenue. This subset of donors provides a consistent foundation of funding, which has been steadily increasing in the last several years.
In FY18, MAPS has maintained its usual Foundation relationships and slightly increased its number of grant proposals. Grant revenue of $6,161,184 was received from family foundations and donor advised funds. In most cases, we have pre-existing relationships with the courageous and visionary donors.
MAPS’ long term account for our assets, The Curing Fund, is managed by the San Francisco Foundation and has been invested in the stock market. At the end of FY17, the MAPS Board of Directors reallocated the portfolio to a short-term investment strategy based on cash flow forecasts that showed drawdowns beginning in December 2017. The Curing Fund began FY18 with a balance of $7,181,216. As projected, drawdowns on the fund of $450,000 began in December. These were more than offset by an additional $6,833,027 in new contributions added through the liquidation of cryptocurrency donations – primarily from December 2017 to March 2018. The success of MAPS’ cryptocurrency and other fundraising efforts over the balance of the year eliminated the need for further drawdowns on The Curing Fund and led to a closing balance of $13,477,459 at fiscal year-end.
MAPS continued its long-running Fiscal Sponsorship program in FY18 with donations totaling $563,743. This program supports projects that are in alignment with MAPS’ mission and vision but are being conducted by organizations that do not have a 501(c)(3) designation. MAPS monitors the project budget, takes a small fee, and sends the donor a receipt for their contribution.
Product sales and event registrations combined generated $254,082 and remain important aspects of our work. A total of 2,408 orders were placed in FY18, reaching more than 25 countries. Events and products serve to draw new supporters, strengthen
our relationships to current supporters, and promote our message.
EXPENSE REVIEW FOR FISCAL YEAR 2017–18
In Fiscal Year 2018, total expenses were $7,774,908. Program costs totaled 83.8% of all expenses. Programs included Research expenses of $4,796,961, Education and Communication expenses of $1,216,352 which includes Harm Reduction of $237,792 and Fiscal Sponsorships of $563,743. Fundraising expenses were $286,897 and Administrative expenses were $874,736.
Our primary expenditure in FY18 was for MDMA-assisted psychotherapy research with expenses of $3,978,141. Of that amount, MAPS spent $3,679,741 on beginning Phase 3 research into MDMA-assisted psychotherapy for PTSD and associated projects. We also completed our study looking at the safety and efficacy of using MDMA-assisted psychotherapy for social anxiety in adults on the autism spectrum ($20,872), with the paper recently published in J. Psychopharmacology, and completed our study of MDMA-assisted psychotherapy for end-of-life anxiety ($34,650), with the paper awaiting submission for publication. An additional $90,843 was spent on the study blending MDMA-assisted psychotherapy with Cognitive Behavioral Conjoint Therapy (CBCT) conducted by Candice Monson, Anne Wagner, Michael and Annie Mithoefer, and $11,060 on the study blending MDMA-assisted psychotherapy with Prolonged Exposure Therapy (PE) at Emory University.
Marijuana research expenses totaled $762,034. In FY16, after seven years of struggle, MAPS finally received DEA and IRB approval to move forward with its study examining the efficacy of smoked marijuana in 76 veterans with chronic, treatment-resistant PTSD. This research is funded by a $2.156 million grant from the Colorado Department of Public Health and Environment (CDPHE). In February 2017, the first participant was enrolled and received cannabis. As of the writing of this report, we have enrolled 75 of the 76 subjects.
Education expenses of $1,216,352 includes events, conferences, publications, communications, psychedelic harm reduction, and fiscal sponsorships. Conferences, events, and initiatives had expenses of $707,072. In FY17, MAPS provided sponsorship, speakers, tables, formal representatives and/or promotional support for over 70 outreach events, doubling the number from FY17.
Communications expenses of $509,280 include active engagement in public education through media contacts, website and social media presence, publishing three MAPS Bulletins, 12 email newsletters and the MAPS Podcast hosted by Zach Leary. We maintain maps.org, mapsbcorp.com, mapscanada.org, zendoproject.org, psychedelicscience.org, psychedelicdinners.org, and mdma-autism.org. In FY18, MAPS received 549 unique media mentions from online and print publications, more than ever before. Media outlets include: Time, Forbes, Rolling Stone, New York Magazine, The Washington Post, Playboy, The New York Times, Fox News, Breitbart, Stars and Stripes, Reuters, The San Francisco Chronicle and many more.
The Zendo Project psychedelic harm reduction program incurred costs of $237,792, with $113,774 of that to support Zendo’s work at Burning Man. The Zendo Project provided services at seven major festivals including: Burning Man, Insomniac events with Project Open Talk, Envision, and Lightning in a Bottle. The Zendo Project provided support to over 670 guests at two locations at Burning Man 2017. Zendo’s location was highlighted on Burning Man’s official map of Black Rock City and Zendo collaborated closely with medical staff, law enforcement from the Bureau of Land Management, and Black Rock City Rangers. A public 3-hour training on the principles of psychedelic harm reduction was hosted for several hundred people. Zendo staff also hosted two integration sessions.
Fundraising expenses were $386,897, an increase of 86% from FY17. However, current fundraising expenses account for only 2% of all contributed revenue for FY18, which is better than national averages (10-20%). MAPS efficiently spends $0.02 in fundraising for every $1 raised. Of the fundraising expenses, $223,303 is primarily for staff, mail and delivery, donor research, and database costs; with another $40,314 for donor meetings and cultivation efforts; and another $123,280 in campaign and fundraising event expenses.
Operational costs were $874,736. These are the unglamorous but necessary expenses of staffing, office rent, taxes, fees, accounting, information technology, equipment, supplies, and postage. Operations accounts for 11% of MAPS expenses.
FISCAL YEAR 2018–19
In FY19, our focus remains on the multi-site Phase 3 studies required for FDA approval of MDMA-assisted psychotherapy for PTSD as a legal prescription treatment. We also anticipate a growing focus on Phase 3 studies required for European Medicines Agency (EMA) regulatory approval. The first Phase 3 study for FDA will have been initiated by the time this Bulletin arrives in MAPS members’ mailboxes. We anticipate submitting our New Drug Application to the FDA in 2021. We are currently training potential European researchers, selecting potential study sites, and preparing regulatory submission in hopes of initiating studies in Europe near the end of FY19, however this is dependent on raising the $9 million needed to fund these studies.
In FY19 there are projected total research expenses of nearly $11.6 million with approximately $1.49 million of this amount earmarked for European studies, about $1.17 million for our education programs including the Zendo Project and Fiscal Sponsorships, with approximately $1.55 million for Fundraising and Administration.
Estimated spending in FY19 is projected to be over $13.25 million, an increase of nearly $5.5 million over FY18, and by far the largest expenditures in a single fiscal year in MAPS’ entire 33-year existence due to the ongoing Phase 3 studies.
MAPS’ fundraising ability has significantly increased now that MAPS has obtained an FDA Agreement Letter successfully concluding our Special Protocol Assessment (SPA) process and been granted FDA Breakthrough Therapy Designation for MDMA-assisted psychotherapy for PTSD, and published Phase 2 results in high impact journals like The Lancet Psychiatry and Psychopharmacology. MAPS has received some major support in FY19, including grants and pledges of $500,000 from Good Ventures, $500,000 from the efforts of Clay Rockefeller and Rebecca Lambert, $100,000 from Lauren Sherman who contributed to MAPS Canada, and $100,000 from Abby Rockefeller.
FY18 was an exceptional year, successfully setting the stage for Phase 3 research on MDMA-assisted psychotherapy for PTSD. Expenses were greater than any other fiscal year to date, yet MAPS managed to raise enough contributions and multi-year pledges to completely fund FDA Phase 3 studies, increasing our net assets temporarily by over $11 million. However, as Phase 3 kicks into high gear in FY19, expenses will grow substantially. The inspiring news about FDA granting MAPS Breakthrough Therapy Designation for MDMA-assisted psychotherapy for PTSD has motivated supporters to step up, confident in the impact of their gift
to heal trauma and legitimize MDMA-assisted psychotherapy as a legally available treatment available by prescription.
As MAPS initiates its Phase 3 MDMA/PTSD studies for FDA, research and educational expenses will continue to increase each year until FY20 when we’ll complete gathering the Phase 3 data. In FY21, MAPS’ FDA Phase 3 research will shift to much less expensive data analytic work and submitting a New Drug Application to FDA.
MAPS’ currently has raised the estimated $26.7 million needed to complete Phase 3 studies for FDA. Now, our fundraising focus turns to EMA Phase 3 studies, which we anticipate will cost approximately $9 million, of which about $900,000 is already raised. MAPS is seeking to raise these funds by the end of FY19. It will be substantially less expensive if we can enroll subjects for the one Phase 3 study for EMA and continue until we have treated enough subjects, than if we have to stop the study to raise more funds.
In FY19, we have conducted discussions with EMA for scientific advice about the study designs for the Phase 3 study, and discussions with FDA and DEA regarding our Breakthrough Therapy Designation. MAPS still needs to demonstrate statistically significant evidence of efficacy in our Phase 3 studies with an acceptable safety profile before FDA will authorize prescription use, but the Breakthrough Therapy Designation allows for discussions about potential commercialization issues prior to the completion of the Phase 3 studies. These discussions will focus on topics related to Expanded Access (compassionate use for PTSD patients prior to actual approval for prescription use), brand names, manufacturing of commercial quantities of GMP MDMA, the Risk Evaluation and Mitigation Strategies (REMS) that will control how MDMA-assisted psychotherapy will be provided by prescription, as well as other topics related to commercialization of MDMA-assisted psychotherapy for PTSD.
We are not there yet, but with the continued support from the MAPS community, the legal prescription use of MDMA will become more than a dream.
If you have questions or comments about anything in the financial report, or would like to become more involved, we invite you to contact askMAPS@maps.org.