Document


 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported): May 3, 2018
 
ADAMAS PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
 
Delaware
 
001-36399
 
42-1560076
(State or other jurisdiction
 
(Commission File Number)
 
(IRS Employer Identification No.)
of incorporation)
 
 
 
 
1900 Powell Street, Suite 750
Emeryville, CA
 
94608
(Address of principal executive offices)
 
(Zip Code)
Registrant’s telephone number, including area code: (510) 450-3500
 

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))

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. ☒

 

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Item 2.02    Results of Operations and Financial Condition.
 
On May 3, 2018, Adamas Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2018. 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 May 3, 2018.


2



SIGNATURES
 
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:
May 3, 2018
By:
/s/ Alfred G. Merriweather
 
 
 
Alfred G. Merriweather
 
 
 
Chief Financial Officer

3
Exhibit
Exhibit 99.1


Adamas Reports First Quarter 2018 Financial Results
GOCOVRI™ (amantadine) extended release capsules product sales hit $2.6 million for the first quarter of commercialization, with 1,608 fulfilled prescriptions
Received positive feedback from the U.S. Food and Drug Administration (FDA) on the clinical development program for ADS-4101 in patients with epilepsy
EMERYVILLE, Calif., May 3, 2018 Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS) today reported financial results and pipeline updates for the first quarter ended March 31, 2018.
“We are pleased with the first quarter of commercialization of GOCOVRI and we are very encouraged by the positive reception we have received from physicians, patients and care partners,” stated Gregory T. Went, Ph.D., Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc. “In addition, our development pipeline continues to advance with the enrollment of patients in our Phase 3 trial of ADS-5102 for multiple sclerosis patients with walking impairment, and we received positive feedback from the FDA on our clinical development plans for ADS-4101, which will allow the program to advance directly into pivotal Phase 3 trials in epilepsy patients with partial onset seizures.”
Recent Highlights
Fulfilled 1,608 paid prescriptions of GOCOVRI, the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, in the first quarter of 2018
Received GOCOVRI prescriptions from 550 distinct prescribers through March 31, 2018
Reported final data from EASE LID 2, the two-year Phase 3 open-label study of GOCOVRI for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy demonstrating durability of effect out to two years
Presented GOCOVRI-related basic research and clinical data at the American Academy of Neurology (AAN) Annual Meeting
Published a manuscript in CNS Drugs showing that 52 percent of GOCOVRI-treated patients in the pooled Phase 3 studies reported a complete resolution of their ON time with troublesome dyskinesia by Week 12
Initiated a Phase 3 study of ADS-5102 (amantadine) extended release capsules in multiple sclerosis patients with walking impairment
Received positive feedback from the U.S. Food and Drug Administration (FDA) regarding the clinical development plans for ADS-4101 (lacosamide) modified release capsules in development for the treatment of partial onset seizures in patients with epilepsy
First Quarter 2018 Financial Results
Adamas recorded revenues from the sale of GOCOVRI of $2.6 million for the first quarter ended March 31, 2018. The full commercial launch of GOCOVRI occurred on January 8, 2018, so there were no similar product sales for the first quarter of 2017. The company recognizes revenue using the sell-in method, typically when products are delivered to the specialty pharmacy.
Research and development (R&D) expenses for the first quarter ended March 31, 2018, were $7.2 million, including $0.8 million in stock-based compensation expense, compared to $7.1 million for the first quarter ended March 31, 2017, which included $0.8 million in stock-based compensation expense.
Selling, general and administrative (SG&A) expenses for the first quarter ended March 31, 2018, were $26.4 million, including $3.0 million in stock-based compensation expense, compared to $9.1 million for the same quarter in the prior year, which included $2.1 million in stock-based compensation expense.
Adamas reported a net loss of $35.0 million, or $1.35 per share, basic and diluted, for the first quarter of 2018, compared to a net loss of $16.0 million, or $0.72 per share, basic and diluted, for the first quarter of 2017. The net losses for the first quarters of 2018 and 2017 included $3.7 million and $2.9 million, respectively, in non-cash stock-based compensation expense.



Cash Position
Adamas ended the quarter with $286.7 million of cash, cash equivalents, and available-for-sale securities, compared to $176.4 million at December 31, 2017. This includes $134.3 million net proceeds the company received from a public offering in January 2018.
Investor Conference Call and Webcast
Adamas will host a conference call and webcast today, May 3, 2018, at 4:30 p.m. Eastern Time. The conference call may be accessed by dialing 844-215-3280 for participants in the U.S. or Canada and 484-747-6383 for international callers. The webcast can be accessed live via the investor section of the Adamas website at http://ir.adamaspharma.com/events-presentations and will be available for replay until June 3, 2018.
About GOCOVRI
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. GOCOVRI is a high-dose 274 mg amantadine (340 mg amantadine hydrochloride) taken once-daily at bedtime, which delivers high levels of amantadine upon waking and throughout the day. Data from two pivotal, placebo-controlled clinical studies in approximately 200 patients demonstrated statistically significant reduction in dyskinesia, as well as a secondary benefit in OFF time in patients dosed with GOCOVRI. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, fall and orthostatic hypotension. For more information about GOCOVRI, including complete safety information, please see the U.S. Prescribing Information at www.gocovri.com.
About ADS-4101
ADS-4101 is an investigational drug in development for the treatment of partial onset seizures in patients with epilepsy. Derived from Adamas’ validated time-dependent biology approach to drug development, ADS-4101 is a potential high-dose, once-daily at bedtime lacosamide therapy, with a drug profile that provides high concentrations of lacosamide during the day to match the time when seizures occur most often. Lacosamide is an anti-epilepsy active ingredient previously approved by the FDA and currently marketed as VIMPAT® (lacosamide).
About Adamas Pharmaceuticals, Inc.
Adamas’ goal is to create and commercialize a new generation of medicines intended to lessen the burden of chronic neurologic diseases on patients, caregivers and society using its deep understanding of time-dependent biology. The company is focused on the commercial launch of GOCOVRI™ (amantadine) extended release capsules (previously ADS-5102), the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, and delivering on its pipeline of differentiated investigational programs. Those programs include: ADS-5102 in development for the treatment of multiple sclerosis walking impairment; and ADS-4101, a high-dose, modified release lacosamide in development for the treatment of partial onset seizures in patients with epilepsy. For more information about Adamas and its unique approach to developing medicines based on time-dependent biology, 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 the commercial acceptance of GOCOVRI, the potential clinical benefits of GOCOVRI or about Adamas’ ongoing or planned clinical development programs, including ADS-5102 and ADS-4101 because such statements are subject to risks and uncertainties, 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 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 May 3, 2018, particularly under the caption “Risk Factors.” 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.
# # #



 
Contact:
Media:
Terri Clevenger
Continuum Health Communications
203-227-0209
tclevenger@continuumhealthcom.com

Investors:
Ashleigh Barreto
Director, Corporate Communications & Investor Relations
Adamas Pharmaceuticals, Inc.
510-450-3567
ir@adamaspharma.com

— Financial Tables Attached —



Adamas Pharmaceuticals, Inc.
Unaudited Condensed Consolidated Statements of Operations
(in thousands, except per share data)
 
 
Three Months Ended
 March 31,
 
2018
 
2017
Revenues:
 
 
 
Product sales
$
2,553

 
$

Costs and operating expenses:
 

 
 

Cost of product sales
25

 

Research and development
7,188

 
7,088

Selling, general and administrative, net
26,363

 
9,144

Total costs and operating expenses
33,576

 
16,232

Loss from operations
(31,023
)
 
(16,232
)
Interest and other income, net
878

 
204

Interest expense
(4,826
)
 

Net loss 
$
(34,971
)
 
$
(16,028
)
Net loss per share, basic and diluted
$
(1.35
)
 
$
(0.72
)
Weighted average shares used in computing net loss per share, basic and diluted
25,861

 
22,206




Adamas Pharmaceuticals, Inc.
Unaudited Consolidated Balance Sheet Data
(in thousands)
 
 
March 31,
2018
 
December 31,
2017
Cash, cash equivalents, and available-for-sale securities
$
286,655

 
$
176,433

Total assets
298,388

 
186,176

Total current liabilities
20,920

 
16,607

Long-term debt
107,105

 
102,647

Total liabilities
128,785

 
120,050

Total stockholders’ equity
169,603

 
66,126