0001328143-21-000072.txt : 20210809 0001328143-21-000072.hdr.sgml : 20210809 20210809160413 ACCESSION NUMBER: 0001328143-21-000072 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20210809 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20210809 DATE AS OF CHANGE: 20210809 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Adamas Pharmaceuticals Inc CENTRAL INDEX KEY: 0001328143 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 421560076 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36399 FILM NUMBER: 211156405 BUSINESS ADDRESS: STREET 1: 1900 POWELL ST., SUITE 1000 CITY: EMERYVILLE STATE: CA ZIP: 94608 BUSINESS PHONE: 510-450-3554 MAIL ADDRESS: STREET 1: 1900 POWELL ST., SUITE 1000 CITY: EMERYVILLE STATE: CA ZIP: 94608 FORMER COMPANY: FORMER CONFORMED NAME: NeuroMolecular Pharmaceuticals Inc DATE OF NAME CHANGE: 20050524 8-K 1 adms-20210809.htm 8-K adms-20210809

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 9, 2021
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
of incorporation)
File Number)
(IRS Employer Identification No.)
1900 Powell Street, Suite 1000
Emeryville, CA 94608
(Address of principal executive office)
Registrant’s telephone number, including area code (510) 450-3500
Not applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions: 
    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.001 per shareADMSThe Nasdaq Global Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). 
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Item 2.02    Results of Operations and Financial Condition.
On August 9, 2021, Adamas Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2021. A copy of the press release is furnished as Exhibit 99.1 to this report.
The information in this Item 2.02 and in the press release furnished as Exhibit 99.1 to this current report shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the press release furnished as Exhibit 99.1 to this current report shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01    Financial Statements and Exhibits.

(d)    Exhibits
Exhibit No.    Description
99.1 Press Release dated August 9, 2021.
Cover Page Interactive Data File (embedded within the Inline XBRL document).


Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Adamas Pharmaceuticals, Inc.
Dated: August 9, 2021By:/s/ Christopher B. Prentiss
  Christopher B. Prentiss
  Chief Financial Officer

EX-99.1 2 adms991q22021earningsrelea.htm EX-99.1 Document
Exhibit 99.1

Adamas reports second quarter 2021 financial results
Second quarter 2021 total revenues of $22.0 million, a 17% increase over second quarter 2020
GOCOVRI new paid prescriptions of 730, a 97% increase over second quarter 2020
EMERYVILLE, Calif., August 9, 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 second quarter ended June 30, 2021, and recent corporate highlights.
“We delivered a strong performance in the second quarter, with a robust increase in demand set to fuel future growth,” said Neil F. McFarlane, Chief Executive Officer. “We remain on track to achieve our 2021 goals as we navigate the fluid macro environment. With the continued momentum of our GOCOVRI launch alongside our disciplined approach to capital allocation, we are excited about the opportunities ahead for patients and shareholders.”
Recent portfolio highlights
Total revenues were $22.0 million in the second quarter of 2021, an increase of 17% as compared to $18.8 million in the second quarter of 2020.
GOCOVRI® (amantadine) extended release capsules product sales were $20.1 million in the second quarter of 2021, an increase of 12% as compared to $18.0 million in the second quarter of 2020.
New paid prescriptions (NRx) of GOCOVRI were approximately 730 in the second quarter of 2021, a 97% increase over NRx of approximately 370 in the second quarter of 2020.
Total paid prescriptions (TRx) of GOCOVRI were approximately 9,400 in the second quarter of 2021, a 19% increase over approximately 7,915 TRx in the second quarter of 2020.
Strong patient persistence of 45%-50% at 12 months for the second quarter of 2021 remains consistent.
Corporate highlights
Recent publications in peer-reviewed journals: new data analyses suggesting GOCOVRI may meaningfully reduce the impact of motor symptoms on activities of daily living published in Neurology and Therapy; and a review article by leading neurologists published in TouchNEUROLOGY supporting GOCOVRI as a clinically significant advance in treating motor complications.
Announced issuance of patents for GOCOVRI, the first in a new patent family, which cover drug product composition and method of use.
First international patent covering ADS-4101, an investigational high-dose, modified release lacosamide capsule for partial onset seizures in patients with epilepsy was issued in Japan. This patent follows two recently issued U.S. patents. These patents may assist efforts to continue to partner or out-license this program.
Received FDA approval of an sNDA for a second and alternative packager for GOCOVRI further bolstering the Company’s supply chain.

Financial results
Total revenues were $22.0 million for the second quarter of 2021, consisting of GOCOVRI product sales of $20.1 million, OSMOLEX ER product sales of $0.5 million and royalty revenue earned on net sales of NAMZARIC® (memantine hydrochloride extended release and donepezil hydrochloride) capsules of $1.4 million. GOCOVRI product sales were up 12% compared to $18.0 million in the same period in 2020.
Research and Development (R&D) expenses
R&D expenses for the second quarter of 2021 were $1.4 million, compared to $2.6 million for the same period in the prior year. The decrease in R&D expenses was primarily due to the completion of the Company’s open-label extension trial for the treatment of multiple sclerosis patients with walking impairment.
Selling, General and Administrative (SG&A) expenses
SG&A expenses for the second quarter of 2021 were $29.2 million, compared to $23.2 million for the same period in the prior year. SG&A expenses in the second quarter of 2021 were primarily attributable to sales force costs and external spend dedicated to GOCOVRI commercialization and the related administrative support as well as the integration and initial promotion of OSMOLEX ER.
Net loss
Net loss was $12.3 million, or $0.27 per share, basic and diluted, for the second quarter of 2021, compared to a net loss of $10.6 million, or $0.37 per share, basic and diluted, for the second quarter of 2020. Net loss for the second quarter of 2021 and 2020 included $1.9 million and $1.7 million, respectively, in non-cash stock-based compensation expense.
Cash and investments
As of June 30, 2021, Adamas had $118.3 million of cash, cash equivalents and available-for-sale securities, compared to $83.4 million as of December 31, 2020. During the first quarter of 2021, the Company raised net proceeds of approximately $66.5 million through the sale of common stock.
Full year 2021 expense guidance
For full year 2021, Adamas is reiterating its estimates for R&D, SG&A and stock-based compensation expenses as set forth below:
Full Year 2021
R&D expenses
$5 million -- $10 million1
SG&A expenses
$110 million -- $120 million2
Total operating expenses
$115 million -- $130 million3
1Includes stock-based compensation expense of $1 million.
2Includes stock-based compensation expense of $8 million.
3Includes stock-based compensation expense of $9 million.

Investor conference call and webcast
Adamas will host a conference call and webcast today, August 9, 2021, at 4:30 p.m. ET (1:30 p.m. PT). The conference call can be accessed by dialing 1-877-407-9716 for participants in the U.S. or Canada and 1-201-493-6779 for international callers. All callers must provide the following Conference ID: 13720109. The webcast can be accessed live via the investor section of the Adamas website at https://ir.adamaspharma.com/events-presentations and will be available for replay for approximately 30 days.
GOCOVRI® (amantadine) extended release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, and as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes.
Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension.
For more information about GOCOVRI, please visit www.GOCOVRI.com.
OSMOLEX ER® (amantadine) extended release tablets, is FDA-approved for the treatment of Parkinson’s disease and drug-induced extrapyramidal reactions (EPR) in adult patients. Drug-induced EPR are involuntary, uncontrollable movements often caused by antipsychotic drug use, that can cause significant disruption for patients and their families.
OSMOLEX ER has an immediate release outer layer and an extended release core and is taken in the morning. The most commonly observed adverse reactions with OSMOLEX ER include nausea, dizziness, lightheadedness, and insomnia.
For more information about OSMOLEX ER, please visit www.OSMOLEX.com.
For more information, please visit www.NAMZARIC.com.
About Adamas
At Adamas our vision is clear - to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.
Forward-looking statements
Statements contained in this press release regarding matters that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to, statements contained in this press release regarding Adamas’ expectations of its full year 2021 expenses. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied by such forward-looking statements. For a description of

risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks relating to Adamas’ research, clinical, development and commercial activities relating to GOCOVRI, OSMOLEX ER, and ADS-5102, and the regulatory and competitive environment and Adamas’ business in general, see Adamas’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 9, 2021, particularly under the caption “Risk Factors.” In addition, the impact that the current COVID-19 pandemic is having and will have on demand for GOCOVRI, and the unknown duration and severity of the COVID-19 pandemic, add additional risk and uncertainty to these forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Adamas undertakes no obligation to update any forward-looking statement in this press release, except as required by law.
# # #

Sarah Mathieson
Vice President, Corporate Communications
Peter Vozzo

— Financial Tables Attached —

Adamas Pharmaceuticals, Inc.
Unaudited Condensed Consolidated Statements of Operations
(in thousands, except per share data)
 Three Months Ended
 June 30,
Six Months Ended
 June 30,
Product sales$20,557 $17,954 $38,535 $32,435 
Royalty revenue1,415 840 2,748 840 
Total revenues21,972 18,794 41,283 33,275 
Costs and operating expenses:    
Cost of product sales527 381 912 953 
Research and development1,448 2,550 3,260 5,015 
Selling, general and administrative, net29,152 23,177 55,791 47,729 
Total costs and operating expenses31,127 26,108 59,963 53,697 
Loss from operations(9,155)(7,314)(18,680)(20,422)
Interest and other income, net280 215 664 299 
Interest expense(3,469)(3,467)(6,901)(7,091)
Net loss $(12,344)$(10,566)$(24,917)$(27,214)
Net loss per share, basic and diluted$(0.27)$(0.37)$(0.62)$(0.97)
Weighted average shares used in computing net loss per share, basic and diluted45,464 28,194 40,344 28,112 

Adamas Pharmaceuticals, Inc.
Unaudited Consolidated Balance Sheet Data
(in thousands)
 June 30,
December 31,
Cash, cash equivalents, and available-for-sale securities$118,256 $83,365 
Total assets150,644 120,029 
Total current liabilities21,824 34,867 
Long-term debt125,541 126,307 
Total liabilities154,677 170,005 
Total stockholders’ deficit(4,033)(49,976)

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