Adamas Pharmaceuticals Inc (ADMS) 10K Annual Reports & 10Q SEC Filings

Second indication received February 2021 for GOCOVRI as an adjunctive treatment to levodopa/carbidopa in Parkinson’s disease patients experiencing OFF episodes

EMERYVILLE, Calif., February 23, 2021 -- Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today reported financial results for the fourth quarter and full year ended December 31, 2020, and recent corporate highlights.

“We are excited with the opportunities ahead of us, including the continued growth of GOCOVRI which is now the first and only medication approved to treat both OFF and dyskinesia motor complications in Parkinson’s disease,” said Neil F. McFarlane, Chief Executive Officer. “Bolstered by the launch of a second indication, GOCOVRI is now approved to treat approximately 400,000 to 500,000 Parkinson’s patients. The significant progress made across the business in 2020 fueled positive momentum into 2021, and we are leveraging this as we continue to successfully execute our long-term growth strategy.”

Recent portfolio highlights

•Total revenues were $21.0 million in the fourth quarter of 2020, an increase of 29% as compared to $16.3 million in the fourth quarter of 2019.

•GOCOVRI® (amantadine) extended release capsules product sales were $19.8 million in the fourth quarter of 2020, an increase of 21% as compared to $16.3 million in the fourth quarter of 2019.

•Total paid prescriptions (TRx) of GOCOVRI were approximately 8,165 in the fourth quarter of 2020, a 14% increase over approximately 7,160 TRx in the fourth quarter of 2019.

•Strong patient persistence of 45%-50% at 12 months continued in the fourth quarter of 2020.

•New paid prescriptions (NRx) of GOCOVRI were approximately 510 in the fourth quarter of 2020, a 19% increase over NRx of approximately 430 in the third quarter of 2020.

•In February 2021, the U.S. Food and Drug Administration approved a second indication for GOCOVRI as an adjunctive treatment to levodopa/carbidopa in Parkinson’s disease patients experiencing OFF episodes.

Corporate highlights

•In January 2021, closed the settlement of patent litigation with Osmotica Pharmaceuticals plc. and completed the acquisition of the global rights to OSMOLEX ER® (amantadine) extended release tablets, expanding Adamas’ neurology portfolio.

•Amended certain key terms of the Royalty-Backed Loan agreement with HealthCare Royalty Partners, which became effective with the closing of the acquisition of OSMOLEX ER.

•In February 2021, announced a settlement agreement with Zydus Worldwide DMCC and Zydus Pharmaceuticals (USA) Inc. (“Zydus”) resolving patent litigation between the two parties relating to Zydus’ ANDA referencing GOCOVRI. Under the agreement Adamas granted Zydus a non-exclusive license to begin selling a generic version of GOCOVRI as of March 4, 2030, or earlier in certain circumstances.

The following information was filed by Adamas Pharmaceuticals Inc (ADMS) on Tuesday, February 23, 2021 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Adamas Pharmaceuticals Inc's 10-K Annual Report:

Financial - Expense Highlight
We evaluated the embedded derivative value as a result of an event of default and the value as a result of increased costs due to a regulatory change and considered both to have no material value based on current assessment of probability, but could become material in future periods if a specified event of default or regulatory change became more probable than is currently estimated.

Financial - Expense Highlight
The decrease in research and development expenses was mainly attributable to: decreased costs related to clinical activity for our Phase 3 study in support of ADS-5102 for the treatment of walking impairment in patients with multiple sclerosis mainly due to completion of the Phase 3 INROADS trial at the end of 2019; decreased costs related to the decision during the second quarter of 2019 to defer additional investment in the development of our product candidate ADS-4101 for the treatment of partial onset seizures in patients with epilepsy; and decreased costs related to early stage programs.
Financial - Expense Highlight
The decrease for the year ended December 31, 2020 was offset in part by a one-time charge of approximately $5.0 million related to a probable loss associated with the OSMOLEX ER settlement of patent litigation, in addition to approximately $1.9 million for GOCOVRI related promotional costs, market research, and other external professional services, as compared to the same period in the prior year.
Financial - Expense Highlight
We anticipate our selling, general and administrative expenses will remain significant and may increase as we continue to support the commercialization of GOCOVRI.
Financial - Expense Highlight
As a result, we expect research and development costs to decrease from 2019 levels for the foreseeable future, based on this focused strategy.
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Interest expense Interest expense decreased...Read more
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Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

Adamas Pharmaceuticals Inc provided additional information to their SEC Filing as exhibits

Exhibit 2.1: Plan Of Acquisition, Reorganization, Arrangement, Liquidation Or Succession

Exhibit 10.6: Material Contract

Exhibit 10.19: Material Contract

Exhibit 10.22: Material Contract

Exhibit 10.31: Material Contract

Exhibit 21.1: Subsidaries Of The Registrant

Exhibit 23.1: Consents Of Experts And Counsel

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Ticker: ADMS
CIK: 1328143
Form Type: 10-K Annual Report
Accession Number: 0001328143-21-000019
Submitted to the SEC: Tue Feb 23 2021 4:01:07 PM EST
Accepted by the SEC: Tue Feb 23 2021
Period: Thursday, December 31, 2020
Industry: Pharmaceutical Preparations

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Adamas Pharmaceuticals Inc (ADMS) SEC Filing 10-K Annual report for the fiscal year ending Thursday, December 31, 2020

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