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Hudson Labs FOI - FDA hold, patient death and European wind down at BLUE


Welcome to our weekly reports featuring impactful and unusual disclosures as extracted by Hudson Labs' algorithms.

Filings from the week of March 2 - March 8.


BLUE struggles to stay afloat, DNMR gets another SEC request, BYND pays entities associated with former board members and GRUB revises expense classifications, non-GAAP metrics ahead of NASDAQ delisting.


Top Red Flags

ENVIVA INC (EVA) | NT 10-K | $5B - Enviva filed their 10-K late because of “complexities arising from the simplification transaction”. The simplification transaction involved Enviva acquiring their former sponsor, Enviva Holdings, and required that they recast their historical financials.

AMERESCO INC (AMRC) | 10-K | $4B - The SEC investigation into revenue recognition and compensation practices in their SAAS business remains open, as does the Audit Committee review into the matter.

PERSHING SQUARE TONTINE HOLDINGS LTD (PSTH) | 10-K/A | $4B - Marcum accidentally said Pershing had a material control weakness causing Pershing to file a 10-K/A to retract “seven additional unintended words”. Oops! In the audit partner’s defense, he had a lot of SPACs to audit. Read the full thread here.


SEC Comments on Climate

For the first time in comment letter history, the SEC is comparing 10-Ks to CSR reports. The SEC made inquiries of the following companies and more! The SEC noted “you provided more expansive disclosure in your CSR report than you provided in your SEC filings”:




10-K | Market Cap: $400M

Danimer filed their 10-K a week late but it was worth the wait.

Daminer received a follow-up request from the SEC for additional documents and information on January 26, 2022. The SEC investigation commenced in May, 2021. Danimer has also been the subject of previous short reports. [1]

Danimer reported ineffective controls related to the “accuracy of quantities billed for product revenue”, “the expense attribution for certain stock-based compensation awards”, “the processing and payment of vendor invoices” and more. [2]

Danimer is replacing their CFO but the old CFO will continue to be employed as the VP of Financial Planning and Analysis. The new CFO is Michael Hojost, the special advisor to the CEO who previously worked at Strategic Materials, Inc and Accuride Corporation. [3]

  1. "On January 26, 2022, we received a follow-up request from the SEC for additional documents and information."

  2. "The material weakness in risk assessment resulted in the following material weaknesses in internal control over financial reporting: (1) ineffective controls over the accuracy of the quantities billed for product revenue, (2) ineffective controls over the expense attribution for certain stock-based compensation awards, (3) ineffective controls over the preparation and review of the tax provision, including the assignment of control operators with requisite knowledge, experience and expertise, and (4) ineffective controls over the processing and payment of vendor invoices for certain contracts with progress billings have been identified and included in management’s assessment."

  3. "Once Mr. Hajost becomes Danimer's Chief Financial Officer, Principal Financial Officer and Principal Accounting Officer, John A. Dowdy, III will no longer serve in those capacities, but will remain employed by Danimer and serve as Danimer’s Senior Vice President of Financial Planning and Analysis."



10-K | Market Cap: $330M

Bluebird is facing a liquidity crisis, raising a substantial doubt of going concern. [1]

As part of their cash management plan, Bluebird is winding down their operations in Europe, moving their headquarters and looking at selling priority review vouchers. [1]

One lovotibeglogene autotemcel (lovo-cel) gene therapy trial patient died and two developed acute myeloid leukemia. Investigators determined it was unlikely that any of the three were the result of lovo-cel. [2]

However, the FDA has placed Bluebird clinical studies of lovo-cel on partial clinical hold. [3]

In November 2021, Bluebird spun off its oncology business under the auspices of “2seventy bio”. The former CEO, CFO and Chief Scientific Officer also left for 2seventy during the spin-off, resulting in substantial management changes at Bluebird. [4]

  1. "Management's plans to alleviate the conditions that raise substantial doubt include reduced 2022 spending, including projected savings through the move of the Company's headquarters to Assembly Row in Somerville, Massachusetts, the orderly wind down of European operations, the potential sale of priority review vouchers that would be issued with anticipated U.S. regulatory approvals of BLAs for beti-cel and eli-cel, and the pursuit of additional cash resources through public or private equity or debt financings."

  2. “In HGB-206 Group A, two patients treated with lovo-cel developed acute myeloid leukemia ("AML"). Following investigation of the cases, it was determined that these were unlikely related to lentiviral insertion from lovo-cel.”...“In HGB-206 Group C, one patient with underlying cardiopulmonary disease and SCD-related complications died 20 months post-treatment; the investigator and an independent monitoring committee agreed his death was unlikely related to lovo-cel.”

  3. "The FDA has placed our clinical studies of lovo-cel on partial clinical hold, and we have no assurance as to what the FDA may require, or the timing, if ever, of when the partial clinical hold may be lifted, or when we may resume enrolling pediatric patients in our clinical studies of lovo-cel."

  4. "Completion of the separation of 2seventy resulted in substantial changes in our board of directors and management. In particular, our former chief executive officer, Nick Leschly, resigned from that position (although Mr. Leschly continues to serve on our board of directors). In addition, Philip Gregory, our former chief scientific officer, and Chip Baird, our former chief financial officer, resigned from their positions with us to join management positions with 2seventy."



10-K | Market Cap: $2.5B

Beyond Meat paid $15M to a law firm that employs a former member of their board of directors and shareholder. [1]

Beyond Meat paid $1M to a consulting firm led by another former board member. [2]

The company excluded the remeasurement of their warranty liability from their Adjusted EBITDA metric. [3]

Beyond Meat also filed their 10-K five minutes after the deadline, pleading technical challenges.

  1. "Michael Pucker Michael A. Pucker, a partner of Latham & Watkins LLP, is a former member of the Company’s Board of Directors and the spouse of Gigi Pritzker Pucker. During 2021 and 2020, Ms. Pucker may have been deemed to be a holder of more than 5% of the Company’s outstanding common stock. In the years ended December 31, 2021 and 2020, the Company made aggregate payments of approximately $15.7 million and $11.1 million to Latham & Watkins LLP for legal services."

  2. "In 2022, the Company entered into a Master Services Agreement with CA Consulting LLC, a restaurant, food tech and beverage consulting firm, led by Don Thompson, one of the former directors on the Company’s Board of Directors who served until the end of his term in May 2021, for strategic consulting services rendered by CA Consulting LLC. In 2021, the Company accrued $1.0 million in payment towards these consulting services. The Company did not incur any such costs in 2020 or 2019."

  3. ""Adjusted EBITDA” is defined as net loss adjusted to exclude, when applicable, income tax (benefit) expense, interest expense, depreciation and amortization expense, restructuring expenses, share-based compensation expense, expenses attributable to COVID-19, remeasurement of our warrant liability, and Other, net, including interest income, loss on extinguishment of debt and foreign currency transaction gains and losses."



20-F | Market Cap: $6.5B

Just Eat (recently merged with Grubhub) will be delisting their shares from the NASDAQ to trade OTC. [1]

In 2021, Just Eat revised the following:

  • Its disaggregation of revenue due to “the evolving landscape of Just Eat”. [2]

  • The classification of “Outsourced service costs incurred in certain markets to reflect more appropriately the nature of the expenses and to further improve presentation.”

  • “€47 million was reclassified from Staff costs to Other operating expenses.”

  • Its definition of Adjusted EBITDA. [3]

Grubhub founder, Matt Mahoney, stepped down from the management board in December 2021. [4]

  1. "On 8 February 2022, further to Just Eat's ongoing review to determine its optimal listing venue, the Company announced that it has formally notified The Nasdaq Stock Market, Inc. of its intent to voluntarily delist its American Depositary Receipts (“ADRs”) from the Nasdaq."

  2. "Just Eat has revised its disaggregation of revenue in 2021 due to the evolving landscape of Just Eat, in particular the diversification of fee and fulfillment models (including those of the newly acquired Grubhub)....The revised disaggregation distinguishes between revenues which are earned directly from orders placed on Just Eat's platforms and revenues which are not."

  3. "In 2021, Just Eat has revised its definition of Adjusted EBITDA to Just Eat's operating income / loss for the period adjusted for depreciation, amortisation, impairments, share-based payments, acquisition- and integration related costs and other items not directly related to underlying operating performance ("Other Items")."

  4. On 8 October 2021, it was announced however that Matt Maloney decided to step down to pursue other opportunities.


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