HRMY · CIK 0001802665
What Harmony Biosciences Holdings, Inc. told the SEC could break it.
1 self-disclosed vulnerability, pulled from its own filings, each in the company’s words, with the source. This is the risk register almost nobody reads.
A limited set so far, we surface every cited disclosure we’ve extracted for HRMY. More may follow as additional filings are processed.
In its own words
What could break it.
Regulatory & policy
- Drug-pricing policy — IRA Medicare price negotiation and the ARP removal of the 100%-of-AMP Medicaid rebate cap (from Jan 1, 2024) on WAKIX, which generates substantially all revenuemedium
Harmony expects WAKIX (pitolisant) to generate substantially all of its revenue for the foreseeable future, concentrating its exposure to U.S. drug-pricing policy on a single branded product. The American Rescue Plan Act eliminated the statutory 100%-of-AMP cap on manufacturers' Medicaid drug-rebate liability effective January 1, 2024 (so rebates can exceed a drug's AMP), and the Inflation Reduction Act requires manufacturers of certain high-spend drugs to negotiate Medicare prices and imposes inflation rebates. As WAKIX scales, these regimes are a specific, structural pricing/reimbursement exposure on its sole revenue driver. A material single-product drug-pricing policy risk.
“The American Rescue Plan Act of 20021 eliminated the statutory cap on manufacturers' Medicaid drug rebate liability, beginning January 1, 2024.”
The hidden graph
Who it depends on, and who depends on it.
Relationships surfaced from filings, including ones disclosed by the other side, which is how the non-obvious ones come to light.
Its suppliers
Thermo Fisher Scientific (Patheon UK Limited)
“we rely on Interor S.A., Corden Pharma Chenôve SAS and Patheon UK Limited to provide intermediate supply ingredients, API and finished products, respectively.”
Cited →Bioprojet (Bioprojet Pharma)
“We paid Bioprojet an initial license fee of $150.0 million, a milestone payment of $50.0 million upon FDA acceptance of the NDA in February 2019”
Cited →Interor S.A.
“we rely on Interor S.A., Corden Pharma Chenôve SAS and Patheon UK Limited to provide intermediate supply ingredients, API and finished products, respectively.”
Cited →Corden Pharma Chenôve SAS
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