SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 2, 2018
ADAMAS PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
(Commission File Number)
(IRS Employer Identification No.)
1900 Powell Street, Suite 750
(Address of principal executive offices)
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. ☒
Item 2.02 Results of Operations and Financial Condition.
On August 2, 2018, Adamas Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 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.
99.1 Press Release dated August 2, 2018.
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.
August 2, 2018
/s/ Alfred G. Merriweather
Alfred G. Merriweather
Chief Financial Officer
Adamas Reports Second Quarter 2018 Financial Results
- GOCOVRI™ (amantadine) extended release capsules product sales reached $7.6 million for the second quarter -
EMERYVILLE, Calif., August 2, 2018 – Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS) today reported financial results and pipeline updates for the second quarter ended June 30, 2018.
“We continue to be pleased with the progress of the GOCOVRI launch in its second quarter of commercialization. It is still early days and our focus remains on educating physicians on the unique profile of GOCOVRI and raising awareness of dyskinesia among people with Parkinson’s disease,” stated Gregory T. Went, Ph.D., Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc. “In addition, we’re excited about early physician and patient interest in our INROADS trial, the Phase 3 controlled study of ADS-5102 in multiple sclerosis patients with walking impairment, and we recently enrolled the first patient in our INROADS3 trial, the open-label extension study.”
Fulfilled approximately 3,430 paid prescriptions of GOCOVRI, the first and only medicine approved
by the U.S. Food and Drug Administration (FDA) indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, in the second quarter of 2018
Received GOCOVRI prescriptions from approximately 970 distinct prescribers through June 30, 2018
Enrolled the first patient in INROADS3, the Phase 3 open-label INvestigational Research Study Of ADS-5102 (amantadine) extended release capsules in multiple sclerosis (MS) walking impairment
Continued to enroll patients in INROADS, the Phase 3 placebo-controlled trial of ADS-5102 in MS walking impairment
Presented new GOCOVRI data analysis of Phase 3 controlled data demonstrating that GOCOVRI reduces transitions between Parkinson’s disease diary states throughout the day
Continued to advance the ADS-4101 (lacosamide) program for the treatment of partial onset seizures in patients with epilepsy by establishing manufacturing capabilities to enable further clinical development
Launched “Dyskinesia is a Jerk™,” a disease education campaign to raise awareness for Parkinson’s disease dyskinesia
Adamas reported GOCOVRI net product sales of $7.6 million for the three months ended June 30, 2018. GOCOVRI net product sales were $10.1 million for the six months ended June 30, 2018. The full commercial launch of GOCOVRI occurred on January 8, 2018, so there were no similar product sales in 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 second quarter ended June 30, 2018, were $9.8 million, including $0.7 million in stock-based compensation expense, compared to $7.2 million for the second quarter ended June 30, 2017, which included $0.9 million in stock-based compensation expense. R&D expenses for the six months ended June 30, 2018 were $17.0 million, including $1.5 million in stock-based compensation expense, compared to $14.3 million for the six months ended June 30, 2017, which included $1.7 million in stock-based compensation expense.
Selling, general and administrative (SG&A) expenses for the second quarter ended June 30, 2018, were $27.7 million, including $3.4 million in stock-based compensation expense, compared to $13.1 million for the same quarter in the prior year, which included $2.9 million in stock-based compensation expense. SG&A expenses for the six months ended June 30, 2018, were $54.1 million, including $6.4 million in stock-based compensation expense, compared to $22.3 million for the six months ended June 30, 2017, which included $4.9 million in stock-based compensation expense.
Adamas reported a net loss of $34.0 million, or $1.26 per share, basic and diluted, for the second quarter of 2018, compared to a net loss of $20.7 million, or $0.93 per share, basic and diluted, for the second quarter of 2017. Net loss for the six months ended June 30, 2018, was $69.0 million, or $2.61 per share, basic and diluted, compared with a net loss for the same period in 2017 of $36.8 million, or $1.65 per share, basic and diluted.
Adamas ended the quarter with $256.3 million of cash, cash equivalents, and available-for-sale securities, compared to $176.4 million at December 31, 2017.
Investor Conference Call and Webcast
Adamas will host a conference call and webcast today, August 2, 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 November 2, 2018.
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.
ADS-5102 is a high-dose amantadine taken once-daily at bedtime, which delivers consistently high levels of amantadine upon waking and throughout the day. ADS-5102 was previously approved by the U.S. Food and Drug Administration (FDA) under the trade name GOCOVRI™ (amantadine) extended release capsules for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. Adamas is currently evaluating ADS-5102 for the treatment of multiple sclerosis patients with walking impairment. GOCOVRI is not FDA-approved for the treatment of walking impairment in multiple sclerosis patients.
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.
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 August 2, 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.
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Director, Corporate Communications & Investor Relations
Adamas Pharmaceuticals, Inc.
Continuum Health Communications
— Financial Tables Attached —
Adamas Pharmaceuticals, Inc.
Unaudited Condensed Consolidated Statements of Operations
(in thousands, except per share data)
Three Months Ended
Six Months Ended
License and grant revenue
Costs and operating expenses:
Cost of product sales
Research and development
Selling, general and administrative, net
Total costs and operating expenses
Loss from operations
Interest and other income, net
Loss before income taxes
Benefit for income taxes
Net loss per share, basic and diluted
Weighted average shares used in computing net loss per share, basic and diluted
Adamas Pharmaceuticals, Inc.
Unaudited Consolidated Balance Sheet Data
Cash, cash equivalents, and available-for-sale securities
Total current liabilities
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