On February 14, 2019 Alkermes plc (Nasdaq: ALKS) reported financial results for the year ended Dec. 31, 2018 and provided financial expectations for 2019 (Press release, Alkermes, FEB 14, 2019, View Source [SID1234533306]).

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"Our strong financial results in 2018 were driven by the growth of our proprietary commercial products and the continued strength and diversity of our royalty and manufacturing business," commented James Frates, Chief Financial Officer of Alkermes. "As we enter 2019, our financial expectations reflect the continued growth of our proprietary products, VIVITROL and ARISTADA, as well as important investments in the future growth drivers of the company including our advancing development pipeline and commercial capabilities to support our expanding presence in schizophrenia."

Quarter Ended Sept. 30, 2018 Financial Highlights

Total revenues for the quarter were $315.8 million. This compared to $275.4 million for the same period in the prior year, representing an increase of 15%. Proprietary product net sales for VIVITROL and ARISTADAi were $132.7 million for the quarter, reflecting a 28% increase compared to the same period in the prior year.

Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $9.7 million for the quarter, or a basic and diluted GAAP net loss per share of $0.06. This compared to GAAP net loss of $9.8 million, or a basic and diluted GAAP net loss per share of $0.06, for the same period in the prior year.

Non-GAAP net income was $54.8 million for the quarter, or a non-GAAP basic earnings per share of $0.35 and non-GAAP diluted earnings per share of $0.34. This compared to non-GAAP net income of $50.3 million, or a non-GAAP basic earnings per share of $0.33 and non-GAAP diluted earnings per share of $0.31, for the same period in the prior year.

The launch of ARISTADA INITIOii continues to gain traction as payers and providers recognize the value proposition of this important new offering, particularly in combination with the ARISTADA two-month dose which provides the unique ability to fully dose a patient on day one for up to two monthsiii. With this offering, we are supporting continuity of care which is critically important for this patient population. We also continue to build the customized commercial capabilities necessary to navigate this complex treatment environment, including recent expansions of our field- and hospital-based teams," stated Jim Robinson, President and Chief Operating Officer of Alkermes. "VIVITROL results for 2018 were in-line with our expectations and we are encouraged by solid growth trends across many states. As we enter 2019, we remain committed to increasing access to VIVITROL and driving increased adoption in order to meet the needs of patients with opioid and alcohol dependence."

Quarter Ended Dec. 31, 2018 Financial Results

Revenues

Net sales of VIVITROL were $83.8 million, compared to $75.6 million for the same period in the prior year, representing an increase of approximately 11%.

Net sales of ARISTADA were $48.8 million, compared to $28.3 million for the same period in the prior year, representing an increase of approximately 72%.

Manufacturing and royalty revenues from RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA were $81.4 million, compared to $78.2 million for the same period in the prior year.

Manufacturing and royalty revenues from AMPYRA/FAMPYRAiv were $38.8 million, compared to $38.1 million for the same period in the prior year, which was above our expectations given generic entry into the market in 2018.

Manufacturing and royalty revenues included $26.7 million from Alkermes’ share of proceeds from the sale of certain royalty streams by Zealand Pharma A/S, related to products using Alkermes’ technology, to Royalty Pharma.

Research and development revenues were $15.6 million, of which $14.4 million related to R&D reimbursement from the company’s collaboration with Biogen for diroximel fumarate, or BIIB098.

Costs and Expenses

Operating expenses were $315.7 million, compared to $269.5 million for the same period in the prior year, primarily reflecting increased investment in the commercialization of ARISTADA and VIVITROL.

Calendar Year 2018 Financial Highlights

Total revenues increased 21% to $1.09 billion in 2018, which included VIVITROL net sales of $302.6 million and ARISTADA net sales of $147.7 million. This compared to total revenues of $903.4 million for 2017, which included VIVITROL net sales of $269.3 million and ARISTADA net sales of $93.5 million. Please see the tables at the end of this press release for a detailed breakdown of the revenues from our key commercial products.

GAAP net loss was $139.3 million, or a basic and diluted GAAP loss per share of $0.90, for 2018. This compared to a GAAP net loss of $157.9 million, or a basic and diluted GAAP loss per share of $1.03, for 2017.

Non-GAAP net income was $97.8 million, or a non-GAAP basic earnings per share of $0.63 and non-GAAP diluted earnings per share of $0.61, for 2018. This compared to non-GAAP net income of $27.8 million, or a non-GAAP basic earnings per share of $0.18 and non-GAAP diluted earnings per share of $0.17, for 2017.

At Dec. 31, 2018, Alkermes recorded cash, cash equivalents and total investments of $620.0 million, compared to $590.7 million at Dec. 31, 2017. At Dec. 31, 2018, the company’s total debt outstanding was $279.3 million, compared to $281.4 million at Dec. 31, 2017.

"Alkermes is defined by our commitment to making medicines that help address critical public health challenges, using our scientific insights to develop medicines that are designed with the real-world needs of patients in mind. Following the positive results of the ALKS 3831 ENLIGHTEN-2 pivotal study and the increasing traction of ARISTADA in the market, we continue to establish our emerging leadership position in the treatment of schizophrenia," said Richard Pops, Chief Executive Officer of Alkermes. "2019 will be an important year for our late-stage pipeline highlighted by the planned submission of the

ALKS 3831 New Drug Application and the regulatory review of the recently submitted New Drug Application for diroximel fumarate for multiple sclerosis, with expected action in the fourth quarter. As development activities surrounding our ALKS 4230 immuno-oncology program gain momentum, we expect to have our first indications of ALKS 4230’s anti-tumor response activity this year, and we look forward to updating you on our progress."

Recent Events:

ALKS 3831

In November 2018, Alkermes announced positive topline results from ENLIGHTEN-2, a pivotal phase 3 study of ALKS 3831 compared to olanzapine in patients with stable schizophrenia. In the study, ALKS 3831 met the pre-specified co-primary endpoints, demonstrating both a lower mean percent weight gain from baseline at six months compared to the olanzapine group and a lower proportion of patients who gained 10% or more of their baseline body weight at six months compared to the olanzapine group.

Diroximel fumarate (BIIB098)

In December 2018, Alkermes and Biogen announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for diroximel fumarate, a novel oral fumarate in development for the treatment of relapsing forms of multiple sclerosis. If approved, Biogen intends to market diroximel fumarate under the brand name VUMERITYTM. This name has been conditionally accepted by the FDA and will be confirmed upon approval.

ALKS 4230

In November 2018, Alkermes presented initial clinical data from the ongoing dose-escalation stage of the phase 1 study for ALKS 4230 at the 2018 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.

ALKS 5461

In January 2019, Alkermes received a Complete Response Letter from the FDA regarding the NDA for ALKS 5461 for the adjunctive treatment of major depressive disorder.

Financial Expectations for 2019

The following outlines the company’s financial expectations for 2019, which include planned investments in the company’s pipeline of development candidates and commercial infrastructure to support the company’s expanding presence in schizophrenia.

Revenues: The company expects total revenues to range from $1.14 billion to $1.19 billion, driven by expected growth of our proprietary products and an expected $150 million milestone payment from Biogen in the fourth quarter related to the potential FDA approval of diroximel fumarate. Included in this total revenue expectation, Alkermes expects VIVITROL net sales to range from $330 million to $350 million, and ARISTADA net sales to range from $210 million to $230 million.

Cost of Goods Manufactured and Sold: The company expects cost of goods manufactured and sold to range from $180 million to $190 million.

Research and Development (R&D) Expenses: The company expects R&D expenses to range from $450 million to $480 million.

Selling, General and Administrative (SG&A) Expenses: The company expects SG&A expenses to range from $590 million to $620 million.

Amortization of Intangible Assets: The company expects amortization of intangibles to be approximately $40 million.

Net Interest Expense: The company expects net interest expense to range from $5 million to $10 million.

Income Tax Expense: The company expects income tax expense to range from $10 million to $15 million.

GAAP Net Loss: The company expects GAAP net loss to range from $135 million to $165 million, or a basic and diluted loss per share of $0.87 to $1.06, based on a weighted average basic and diluted share count of approximately 156 million shares outstanding.

Non-GAAP Net Income: The company expects non-GAAP net income to range from $40 million to $70 million, or a non-GAAP basic earnings per share of $0.26 to $0.45, based on a weighted average basic share count of approximately 156 million shares outstanding and a non-GAAP diluted earnings per share of $0.25 to $0.43, based on a weighted average diluted share count of approximately 161 million shares outstanding.

Share-Based Compensation: The company expects share-based compensation of approximately $120 million.

Capital Expenditures: The company expects capital expenditures to range from $90 million to $100 million.

Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:30 a.m. ET (1:30 p.m. BST) on Thursday, Feb. 14, 2019, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Thursday, Feb. 14, 2019, through Thursday, Feb. 21, 2019, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay conference ID is 13687392.

On February 14, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported the pricing of its offering of $65.0 million aggregate principal amount of 6.50% convertible senior notes due 2024 (the "notes") (Press release, Inovio, FEB 14, 2019, View Source [SID1234533304]). The notes will be sold in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). The sale of the notes is expected to close on February 19, 2019, subject to customary closing conditions. Inovio also granted the initial purchasers of the notes a 13-day option to purchase up to an additional $20.0 million aggregate principal amount of notes.

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The notes will be senior unsecured obligations of Inovio and will accrue interest payable in cash semi-annually in arrears at a rate of 6.50% per annum. The notes will mature on March 1, 2024, unless earlier converted, redeemed or repurchased. Prior to the close of business on the business day immediately preceding November 1, 2023, the notes will be convertible at the option of the holders only upon the satisfaction of certain circumstances. Thereafter, the notes will be convertible at the option of the holders at any time until the close of business on the scheduled trading day immediately before the maturity date. Upon conversion, Inovio will pay or deliver, as the case may be, cash, shares of its common stock or a combination of cash and shares of its common stock, at its election. The initial conversion rate will be 185.8045 shares per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $5.38 per share), subject to adjustment upon the occurrence of specified events.

Inovio may not redeem the notes prior to March 1, 2022. On or after March 1, 2022, Inovio may redeem all, or any portion, of the notes for cash if the last reported sale price per share of Inovio’s common stock exceeds 130% of the conversion price on (i) each of at least 20 trading days (whether or not consecutive) during the 30 consecutive trading days ending on, and including, the trading day immediately before Inovio sends the related redemption notice; and (ii) the trading day immediately before the date Inovio sends such redemption notice. The redemption price will be equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

Inovio estimates that the net proceeds from the offering will be approximately $62.7 million (or approximately $82.1 million if the initial purchasers exercise in full their option to purchase additional notes), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses payable by Inovio. Inovio intends to use the net proceeds from the offering for general corporate purposes, including clinical trial expenses, research and development expenses, general and administrative expenses and manufacturing expenses, and for other business development activities.

The offer and sale of the notes and the shares, if any, issuable upon conversion of the notes have not been and will not be registered under the Securities Act or applicable state securities laws, and the notes and such shares may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy the notes or any shares issuable upon conversion of the notes, nor shall there be any sale of the notes or such shares, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful.

On February 14, 2019 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported business highlights and financial results for the fourth quarter and year ended December 31, 2018 (Press release, Agios Pharmaceuticals, FEB 14, 2019, View Source [SID1234533303]).

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In addition, Agios highlighted select 2019 corporate milestones and data presentations for its clinical development programs.

"I’m excited to join the Agios team on the heels of a transformational year for the company. During 2018, we launched our first wholly owned oncology medicine, expanded our clinical programs across both oncology and rare genetic diseases, and continued to advance our robust research pipeline," said Jackie Fouse, Ph.D. "We start 2019 with a strong foundation on which to build and with the opportunity to make a meaningful impact on patients’ lives and our business. Our objectives for this year focus on broadening the potential of our IDH inhibitors in AML and solid tumors, advancing mitapivat and AG-270 through clinical development, and remaining steadfast in our pursuit of great science."

KEY UPCOMING MILESTONES

The company plans to achieve the following key milestones in 2019:

Cancer:

Potential FDA approval of the supplemental new drug application (sNDA) for single agent TIBSOVO (ivosidenib) for the treatment of patients with newly diagnosed AML with an IDH1 mutation who are not eligible for standard therapy and subsequent launch in this indication in the U.S.
Submit an sNDA to the FDA for TIBSOVO for second line or later IDH1 mutant cholangiocarcinoma by year-end.
Initiate a registration-enabling Phase 3 study of vorasidenib (AG-881) in low-grade glioma with an IDH1 mutation by year-end.
Determine recommended dose of AG-270, a first-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor, in methylthioadenosine phosphorylase (MTAP)-deleted tumors; initiate expansion arms, including a single-agent arm in a variety of MTAP-deleted cancers and a combination arm in a solid tumor in the first half of 2019.
Initiate a Phase 1 dose-escalation trial of AG-636, an inhibitor of the metabolic enzyme dihydroorotate dehydrogenase (DHODH), in lymphoma in the first half of 2019.
Rare Genetic Diseases:

Complete enrollment in two global pivotal trials for mitapivat in adults with pyruvate kinase (PK) deficiency by year-end 2019:
ACTIVATE-T: A single-arm trial of approximately 20 regularly transfused patients
ACTIVATE: A 1:1 randomized, placebo-controlled trial of 80 patients who do not receive regular transfusions
Achieve proof-of-concept for mitapivat in thalassemia in the second half of 2019.
ANTICIPATED KEY 2019 DATA PRESENTATIONS

Updated data from the ongoing Phase 1 combination trial of TIBSOVO with azacitidine in patients with newly diagnosed AML with an IDH1 mutation to be presented at the 17th International Symposium on Acute Leukemias taking place February 24-27, 2019 in Munich.
Preclinical data for AG-270 accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting taking place March 29-April 3, 2019 in Atlanta.
Data from the perioperative ‘window’ trial with TIBSOVO and vorasidenib in IDHm low-grade glioma submitted for presentation at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 31-June 4, 2019 in Chicago.
Topline data from the Phase 3 ClarIDHy study of TIBSOVO in IDH1 mutant second line or later cholangiocarcinoma to be reported in the first half and full data to be presented in the second half of 2019.
Data from the dose-escalation portion of the ongoing Phase 1 study of AG-270 in patients with MTAP-deleted tumors expected in the second half of 2019.
FOURTH QUARTER 2018 HIGHLIGHTS & RECENT PROGRESS

Submitted an sNDA to the FDA for TIBSOVO for the treatment of patients with newly diagnosed AML with an IDH1 mutation who are not eligible for standard therapy.
Submitted and received validation for a Marketing Authorization Application to the European Medicines Agency for TIBSOVO for the treatment of adult patients with R/R AML with an IDH1 mutation.
Completed enrollment in the Phase 3 ClarIDHy study of TIBSOVO in IDH1 mutant second line or later cholangiocarcinoma.
Initiated a Phase 2 proof-of-concept trial of mitapivat in thalassemia.
Received FDA clearance of an IND application for AG-636, a DHODH inhibitor.
FOURTH QUARTER AND FULL YEAR 2018 FINANCIAL RESULTS

Revenue: Total revenue for the fourth quarter of 2018 was $30.0 million, which includes $18.4 million in collaboration revenue, $9.4 million of net product revenue from U.S. sales of TIBSOVO and $2.2 million in royalty revenue from net global sales of IDHIFA under our collaboration agreement with Celgene. This compares to $9.8 million for the fourth quarter of 2017, which included $8.6 million in collaboration revenue and $1.2 million in royalty revenue from net global sales of IDHIFA. Total revenue was $94.4 million for the year ended December 31, 2018 compared to $43.0 million for the year ended December 31, 2017. The increases in revenue are primarily driven by net U.S. sales of TIBSOVO, additional collaboration revenue and royalty revenue from net U.S. sales of IDHIFA.

Cost of Sales: We began U.S. sales of TIBSOVO in the third quarter of 2018. Cost of sales were $0.7 million for the fourth quarter of 2018, and $1.4 million for the year ended December 31, 2018.

Research and Development (R&D) Expenses: R&D expenses were $93.8 million for the fourth quarter of 2018 compared to $77.2 million for the fourth quarter of 2017, and $341.3 million for the year ended December 31, 2018 compared to $292.7 million for the comparable period in 2017. The increase in R&D expense was primarily attributable to start-up costs for the mitapivat pivotal program in PK deficiency and Phase 2 study in thalassemia and IND enabling activities for AG-636, our DHODH inhibitor. R&D expense also increased as a result of ongoing research efforts across our discovery platform programs.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $31.9 million for the fourth quarter of 2018 compared to $22.7 million for the fourth quarter of 2017, and $114.1 million for the year ended December 31, 2018 compared to $71.1 million for the year ended December 31, 2017. The increase in SG&A expense was primarily attributable to costs to support commercialization of TIBSOVO and personnel costs related to increased headcount.

Net Loss: Net loss was $91.8 million for the fourth quarter of 2018 compared to $88.3 million for the fourth quarter of 2017, and $346.0 million for the year ended December 31, 2018 was compared to a net loss of $314.7 million for the year ended December 31, 2017.

Cash Position and Guidance: Cash, cash equivalents and marketable securities as of December 31, 2018 were $805.4 million compared to $567.8 million as of December 31, 2017. The change in cash was primarily driven by the net proceeds of $516.2 million from the January follow-on offering. The company expects that its cash, cash equivalents and marketable securities as of December 31, 2018, together with anticipated product and royalty revenue, anticipated interest income, and anticipated expense reimbursements under our collaboration and license agreements, but excluding any additional program-specific milestone payments, will enable the company to fund its anticipated operating expenses and capital expenditure requirements through at least the end of 2020.

CONFERENCE CALL INFORMATION

Agios will host a conference call and live webcast with slides today at 8:00 a.m. ET to discuss fourth quarter and full year 2018 financial results and recent business activities. To participate in the conference call, please dial 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and referring to conference ID 9886713. The live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The archived webcast will be available on the company’s website beginning approximately two hours after the event.

On February 14, 2019 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported its financial and pipeline updates for the fourth quarter and full year ended December 31, 2018 (Press release, Acorda Therapeutics, FEB 14, 2019, View Source [SID1234533302]).

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"Our top priority for 2019 is to ensure a successful launch of INBRIJA," said Ron Cohen, M.D., Acorda’s President and CEO. "Our field sales and medical teams have been meeting with Movement Disorder specialists and their office staffs to educate them about INBRIJA’s clinical profile, proper use of the inhaler and our comprehensive patient support services. We are finding strong receptiveness to this novel on-demand treatment for OFF periods."

"The approval of INBRIJA has now validated the innovative ARCUS technology, which allows relatively large doses of drug to be delivered through inhalation. We plan to apply the ARCUS platform to develop therapies for additional indications, including acute migraine, and we look forward to discussing future development milestones later this year."

Fourth Quarter 2018 Financial Results

For the quarter ended December 31, 2018, the Company reported AMPYRA net revenue of $64.2 million compared to $167.2 million for the same quarter in 2017. In September 2018, AMPYRA lost its exclusivity and generics entered the market. Acorda has stated that there would be a significant decline in AMPYRA revenue as a result.

Research and development (R&D) expenses for the quarter ended December 31, 2018 were $27.1 million, including $1.2 million of share-based compensation compared to $35.1 million, including $2.2 million of share-based compensation for the same quarter in 2017.

Sales, general and administrative (SG&A) expenses for the quarter ended December 31, 2018 were $36.8 million, including $3.8 million of share-based compensation compared to $39.5 million, including $5.4 million of share-based compensation for the same quarter in 2017.

Benefit from income taxes for the quarter ended December 31, 2018 was $63.1 million, compared to a benefit from income taxes of $51.9 million for the same quarter in 2017.

The Company reported GAAP net income of $9.6 million for the quarter ended December 31, 2018, or $0.20 per diluted share. GAAP net loss in the same quarter of 2017 was $(171.1) million, or $(3.70) per diluted share.

Non-GAAP net income for the quarter ended December 31, 2018 was $21.5 million, or $0.45 per diluted share. Non-GAAP net income in the same quarter of 2017 was $28.5 million, or $0.61 per diluted share. This quarterly non-GAAP net income measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, restructuring expenses, changes in the fair value of acquired contingent consideration, asset impairment charges and gain on sale of assets. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

Financial Results – Full Year Ended December 31, 2018

For the full year ended December 31, 2018, the Company reported Ampyra net revenue of $455.1 million compared to $543.3 million for the full year 2017. In September 2018, AMPYRA lost its exclusivity and generics entered the market. Acorda has stated that there would be a significant decline in AMPYRA revenue as a result.

Research and development (R&D) expenses for the full year ended December 31, 2018 were $106.4 million, including $5.6 million of share-based compensation, compared to $166.1 million, including $9.7 million of share-based compensation for the full year 2017.

Sales, general and administrative (SG&A) expenses for the full year ended December 31, 2018 were $172.3 million, including $15.7 million of share-based compensation, compared to $181.6 million, including $23.1 million of share-based compensation for the full year 2017.

Benefit from income taxes for the full year ended December 31, 2018 was $13.3 million, compared to a benefit from income taxes of $28.5 million for the full year 2017.

For the full year ended December 31, 2018, the Company reported GAAP net income of $33.7 million, or $0.71 per diluted share. GAAP net loss for the full year 2017 was $(223.4) million, or $(4.86) per diluted share.

Non-GAAP net income for the full year ended December 31, 2018 was $103.4 million, or $2.18 per diluted share. Non-GAAP net income for the full year ended December 31, 2017 was $80.7 million, or $1.75 per diluted share. This full year non-GAAP net income measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, restructuring expenses, changes in the fair value of acquired contingent consideration, asset impairment charges, gain on sale of assets, realized foreign currency loss and acquisition related expenses. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At December 31, 2018, the Company had cash, cash equivalents and investments of $445 million.

2019 Financial Guidance

During INBRIJA’s launch year, the Company does not expect to provide INBRIJA revenue guidance.
The Company will no longer provide revenue guidance for AMPYRA, due to the unpredictable trajectory of revenue decline given the entrance of generics.
R&D expenses for the full year 2019 are expected to be $70-$80 million and SG&A expenses for the full year 2019 are expected to be $200-$210 million. This guidance is a non-GAAP projection that excludes share-based compensation as more fully described below under "Non-GAAP Financial Measures."
Fourth Quarter 2018 Highlights

INBRIJA (levodopa inhalation powder)
On December 21, 2018, INBRIJA was approved by the FDA for intermittent treatment of OFF episodes in people with Parkinson’s taking carbidopa/levodopa. It is not known if INBRIJA is safe or effective in children.
The Company’s Marketing Authorization Application (MAA) for INBRIJA is currently under review by the European Medicines Agency (EMA). After the adoption of a CHMP (Committee for Medicinal Products for Human Use) opinion, the Company expects a final decision from the European Commission before the end of 2019.
In January 2019, TheLancet Neurology published results from SPAN℠-PD, the Phase 3 pivotal trial of INBRIJA.
AMPYRA (dalfampridine) Patent Appeal
In January 2019, the Federal Circuit denied Acorda’s petition for an en banc hearing in the AMPYRA patent appeal process. The Company intends to file a petition for certiorari appealing the case to the U.S. Supreme Court.
Webcast and Conference Call

The Company will host a conference call and webcast in conjunction with its fourth quarter/year end 2018 update and financial results today at 4:30 p.m. ET. To participate in the conference call, please dial (866) 393-4306 (domestic) or (734) 385-2616 (international) and reference the access code 2726179. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 5:30 p.m. ET on February 14, 2019 until 11:59 p.m. ET on March 16, 2019. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international); reference code 2726179. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

Non-GAAP Financial Measures

This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and also certain historical and forward-looking non-GAAP financial measures. In particular, Acorda has provided non-GAAP net income, adjusted to exclude the items below, and has provided 2019 guidance for R&D and SG&A expenses on a non-GAAP basis. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes the presentation of non-GAAP net income, when viewed in conjunction with our GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because this measure excludes (i) non-cash compensation charges and benefits that are substantially dependent on changes in the market price of our common stock, (ii) non-cash interest charges related to the accounting for our outstanding convertible debt which are in excess of the actual interest expense owing on such convertible debt, as well as non-cash interest related to the Fampyra monetization, the asset based loan which was terminated in 2017 and acquired Biotie debt, (iii) changes in the fair value of acquired contingent consideration which do not correlate to our actual cash payment obligations in the relevant periods, (iv) acquisition related expenses and related foreign currency losses that pertain to a non-recurring event, (v) expenses that pertain to non-routine restructuring events, (vi) asset impairments which are non-cash charges that relate to program terminations that are not routine to the operation of the business, and (vii) gain on sale of assets that pertains to non-routine events. The Company believes its non-GAAP net income measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding projected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.

In addition to non-GAAP net income, we have provided 2019 guidance for R&D and SG&A expenses on a non-GAAP basis. Due to the forward looking nature of this information, the amount of compensation charges and benefits needed to reconcile these measures to the most directly comparable GAAP financial measures is dependent on future changes in the market price of our common stock and is not available at this time. The Company believes that these non-GAAP measures, when viewed in conjunction with our GAAP results, provide investors with a more meaningful understanding of our ongoing and projected R&D and SG&A expenses. Also, management uses these non-GAAP financial measures to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.

On February 14, 2019 Scientific teams from NantHealth (NASDAQ: NH) and NantOmics reported that it will present two posters at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium this week (Press release, NantHealth, FEB 14, 2019, View Source;p=RssLanding&cat=news&id=2387497 [SID1234533300]). The two companies, respective leaders in molecular profiling research and genomic testing solutions, teamed together to explore the significance of RNA expression and individual biomarkers in determining why some patients do not respond to targeted cancer therapies based on DNA genomic profiling alone.

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The first poster session will provide insights on individual biomarkers obtained from liquid biopsies that may potentially improve immune checkpoint therapies for prostate cancer. The second session will feature research, conducted with experts from the UC San Diego Health Moores Cancer Center, that demonstrates the benefits of examining discrepancies between DNA alterations and RNA expression that could be the cause of treatment failure for people with metastatic kidney, bladder, and prostate cancer.

"While next generation sequencing for advanced cancers has become routine, not all patients are responding to targeted treatments based solely on DNA genomic profiling," said Sandeep "Bobby" Reddy, MD, Chief Medical Officer, NantHealth. "It is becoming clear that we must delve deeper into RNA expression, as well as identify key biomarkers, to develop effective cancer treatments and therapies."

NantHealth and NantOmics will present the following posters at this year’s Genitourinary Cancers Symposium:

Concomitant characterization of androgen receptor (AC) and immune checkpoints (ICs) in cell-free (cf) DNA and RNA from patients with metastatic castration resistant prostate cancer (mCRPC) – 11:30AM-1:00PM & 5:30PM-6:30PM, 2/14/2019, Session A, Board M21, Abstract #286
RNA sequencing in addition to next generation sequencing in advanced genitourinary cancers reveals transcriptomic silencing of DNA mutations: Implications for resistance to targeted therapeutics – 7:00AM-7:55AM & 12:30PM-2:00PM, 2/16/2019, Session C, Board E22, Abstract #583
The 2019 Genitourinary (GU) Cancers Symposium is a three-day scientific and educational meeting in San Francisco designed to meet the needs of physicians and other members of the cancer care and research community who diagnose, treat, and study GU malignancies.