Adamas Reports Second Quarter 2021 Financial Results

Rhea-AI Summary

Adamas Pharmaceuticals (Nasdaq: ADMS) reported a 17% increase in total revenues to $22.0 million for Q2 2021, driven by GOCOVRI sales of $20.1 million, a 12% rise from the previous year. New paid prescriptions for GOCOVRI surged 97% to approximately 730. R&D expenses fell to $1.4 million, down from $2.6 million year-over-year, while SG&A expenses rose to $29.2 million. The net loss increased to $12.3 million, or $0.27 per share. As of June 30, 2021, cash reserves stood at $118.3 million, bolstered by a $66.5 million stock sale earlier this year.

Positive

• Total revenues increased 17% year-over-year to $22.0 million.
• GOCOVRI sales reached $20.1 million, a 12% increase compared to the prior year.
• New paid prescriptions for GOCOVRI grew by 97% to approximately 730.
• R&D expenses decreased to $1.4 million from $2.6 million.
• Cash and investments rose to $118.3 million, up from $83.4 million at year-end 2020.

Negative

• SG&A expenses increased to $29.2 million from $23.2 million year-over-year.
• Net loss widened to $12.3 million, compared to a $10.6 million loss in Q2 2020.

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

Revenue

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.

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, 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.

About OSMOLEX ER

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.

NAMZARIC

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.

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,
		2021				2020				2021				2020
Revenues:
Product sales		$	20,557			$	17,954			$	38,535			$	32,435
Royalty revenue		1,415				840				2,748				840
Total revenues		21,972				18,794				41,283				33,275
Costs and operating expenses:
Cost of product sales		527				381				912				953
Research and development		1,448				2,550				3,260				5,015
Selling, general and administrative, net		29,152				23,177				55,791				47,729
Total costs and operating expenses		31,127				26,108				59,963				53,697
Loss from operations		(9,155)				(7,314)				(18,680)				(20,422)
Interest and other income, net		280				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 diluted		45,464				28,194				40,344				28,112

Adamas Pharmaceuticals, Inc. Unaudited Consolidated Balance Sheet Data (in thousands)
		June 30, 2021				December 31, 2020
Cash, cash equivalents, and available-for-sale securities		$	118,256			$	83,365
Total assets		150,644				120,029
Total current liabilities		21,824				34,867
Long-term debt		125,541				126,307
Total liabilities		154,677				170,005
Total stockholders’ deficit		(4,033)				(49,976)

 

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FAQ

What were the revenue results for Adamas Pharmaceuticals in Q2 2021?

Adamas Pharmaceuticals reported total revenues of $22.0 million for Q2 2021, a 17% increase from $18.8 million in Q2 2020.

How did GOCOVRI sales perform in Q2 2021?

GOCOVRI sales reached $20.1 million in Q2 2021, reflecting a 12% increase compared to $18.0 million in the same period last year.

What was the net loss for Adamas Pharmaceuticals in Q2 2021?

The net loss for Q2 2021 was $12.3 million, or $0.27 per share, compared to a loss of $10.6 million, or $0.37 per share, in Q2 2020.

What is the cash position of Adamas Pharmaceuticals as of June 30, 2021?

As of June 30, 2021, Adamas Pharmaceuticals had $118.3 million in cash, cash equivalents, and available-for-sale securities.

What guidance has Adamas Pharmaceuticals provided for 2021 R&D and SG&A expenses?

Adamas has reiterated its full-year 2021 estimates for R&D expenses at $5 million to $10 million and SG&A expenses at $110 million to $120 million.