On February 14, 2019 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the Leerink Partners Global Healthcare Conference on Wednesday, February 27, 2019 (Press release, Eli Lilly, FEB 14, 2019, View Source [SID1234533344]). Christi Shaw, president of Lilly Bio-Medicines, will participate in a fireside chat at 1:00 p.m., Eastern Time.

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s investor website at View Source A replay of the fireside chat will be available for approximately 90 days

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, 2018 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the fourth-quarter and full-year 2018 and provided financial guidance for full-year 2019 (Press release, West Pharmaceutical Services, FEB 14, 2019, View Source [SID1234533322]).

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Executive Summary

Fourth-quarter 2018 reported net sales were $422.5 million, representing growth of 1.7% over last year’s period and constant-currency, organic sales growth of 3.6%. Fourth-quarter 2018 reported net sales included a negative adjustment of $11.3 million associated with a voluntary recall of the Company’s Vial2Bag hospital administration system devices. Excluding that impact, sales would have grown by 4.4% over the same period last year, with constant-currency, organic sales growth of 6.3% over last year.
Fourth-quarter 2018 reported-diluted EPS was $0.69, compared to $0.00 in the same period last year, which included a negative impact of $0.64 from 2017 tax law changes. Fourth-quarter 2018 adjusted-diluted EPS was $0.73, compared to $0.64 in the same period last year.
Full-year 2018 reported net sales were $1.717 billion, representing growth of 7.4% over the prior year and constant-currency, organic sales growth of 5.6%.
Full-year 2018 reported-diluted EPS was $2.74, compared to $1.99 last year. Full-year 2018 adjusted-diluted EPS was $2.81, compared to $2.78 in the prior year. Tax benefits from stock-based compensation contributed $0.19 to full-year 2018 adjusted-diluted EPS, compared to $0.44 to full-year 2017 adjusted-diluted EPS.
On January 24, 2019, the Company issued a voluntary recall of its Vial2Bag products due to reports of potential variable dosing associated with the Vial2Bag DC 13 mm device. Given our focus on patient safety, we are recalling all our Vial2Bag products while continuing our root cause analysis. In 2018, Vial2Bag product sales, excluding the impact of the voluntary recall, would have been approximately $24 million.
The Company is introducing full-year 2019 financial guidance. Based on current foreign currency exchange rates, full-year 2019 net sales are expected to be in a range between $1.795 billion and $1.820 billion. Full-year 2019 adjusted-diluted EPS is expected to be in a range between $2.77 and $2.89. This EPS guidance includes the net impact from foreign currency exchange rates but does not include potential tax benefits from stock-based compensation.
"Adjusted-diluted EPS," "net sales at constant currency" and "organic sales" are Non-GAAP measurements. See discussion under the heading "Non-GAAP Financial Measures" in this release.

Executive Commentary

"Our teams have executed on our market-led strategy that focuses on the containment and delivery of injectable medicines and globalizing our operations. I am pleased with the progress on our strategic priorities, which positions us well for 2019," said Eric M. Green, President and Chief Executive Officer. "We are developing next-generation, high-value components and self-injection devices, which are gaining momentum in customer uptake. Entering its second full-year, our Global Operations team is successfully generating substantial efficiencies and greater plant utilization, while concurrently increasing our industry-leading quality metrics and lowering our capital spending requirements.

"With respect to the voluntary Vial2Bag product recall, we strongly believe that these devices significantly advance the standard of care for medicines delivered by way of infusion. Our teams are working to resupply the market as soon as is reasonably possible, in consultation with the United States Food and Drug Administration and other regulatory bodies."

Mr. Green concluded, "Our diverse product portfolio of high-value products and services, as well as new products and line extensions to be launched this year, are addressing the needs of our distinct customer groups. We expect to grow sales and expand profit margins in line with our long-term financial construct, with full-year 2019 constant-currency organic sales growth in a range between 6% and 8%, full-year 2019 operating profit margin expansion of approximately 100 basis points, and adjusted-diluted EPS in a range between $2.77 and $2.89."

Fourth-Quarter and Full-Year 2018 Financial Results (comparisons to prior-year periods)

Fourth-quarter 2018 reported net sales of $422.5 million grew 1.7% over the prior-year quarter. At constant-currency, organic sales growth was 3.6%. Proprietary Products segment organic sales growth was 3.7%, led by mid-single digit growth in both our Biologics and Generics market units. Pharma market unit organic sales growth was flat, affected by the voluntary recall. High-value product (HVP) sales growth was 1%, with mid-single digit growth in HVP component sales, led by double-digit sales growth in NovaPure, FluroTec and Westar RU components, partially offset by the impact from the voluntary recall. Contract-Manufactured Products segment organic sales growth was 3.1%, as continued growth in diabetes-related diagnostic and delivery devices more than offset a year-over-year decline in consumer products and a strong tooling sales quarter in the prior-year period.

Full-year 2018 reported net sales of $1.717 billion grew 7.4% over the prior year. At constant currency, organic sales growth was 5.6%. Proprietary Products organic sales growth was 3.9% led by high-single digit sales growth in the Generics market unit. The Pharma market unit organic sales grew in the low-single digits, and the Biologics market unit had flat organic sales growth. High-value product sales grew in the mid-single digits, led by NovaPure, FluroTec and Westar RU components. Contract-Manufactured Products segment organic sales growth was 11.6% led by healthcare-related products, partially offset by a decline in consumer-related products.

Fourth-quarter 2018 gross profit margin was 31.5%, an increase of 60 basis points from the prior-year period. Proprietary Product segment gross profit margin increased by 220 basis points due to higher efficiencies and positive sales mix, more than offsetting the impact from the voluntary recall, unabsorbed overhead from the start-up of our Waterford facility and higher raw material costs. Contract-Manufactured Products segment gross profit margin declined by 370 basis points due to unabsorbed overhead from plant consolidation activities, start-up costs associated with the launch of new programs and unfavorable sales mix.

Full-year 2018 gross profit margin was 31.8%, a 30-basis point decline from the prior year. While Proprietary Products segment gross profit margin expanded by 80 basis points, Contract-Manufactured Products segment gross profit margin declined by 280 basis points due to unabsorbed overhead from plant consolidation activities, start-up costs associated with the launch of new programs and unfavorable sales mix.

As of January 1, 2018, the Company adopted new rules for pension accounting. Instead of recognizing pension gains or losses in the "Selling, general and administrative expenses" line on the income statement, these gains or losses are now located "below the line" in nonoperating income. The Company has restated all prior periods to enable more accurate year-over-year comparisons with 2018 performance.

Fourth-quarter 2018 reported operating profit margin was 15.6%. Excluding restructuring costs and related charges, fourth-quarter 2018 adjusted operating profit margin was 15.9%, 140 basis points higher than in the prior-year period.

Full-year 2018 reported operating profit margin was 14.0%. Excluding restructuring and related charges and other charges, full-year 2018 adjusted operating profit margin was 14.5%, a decline of 30 basis points compared to the prior-year period.

Fourth-quarter 2018 reported tax rate was 22.7%. Excluding restructuring and related charges and other charges, the adjusted tax rate was 20.1%. This included $1.1 million of tax benefits associated with stock-based compensation. Excluding these benefits, the adjusted tax rate would have been 21.7%.

Full-year 2018 reported tax rate was 17.2%. On an adjusted basis, the tax rate was 18.2%. This included $14.3 million of tax benefits associated with stock-based compensation. Excluding these benefits, the adjusted effective tax rate would have been 24.0%.

Full-year 2018 operating cash flow was $288.6 million, representing a 9.6% increase over 2017 operating cash flow of $263.3 million. Capital expenditures in 2018 were $104.7 million, a 20% reduction compared to 2017 capital expenditures of $130.8 million.

Full-Year 2019 Financial Guidance

The Company expects full-year 2019 net sales to be in a range between $1.795 billion and $1.820 billion, which includes an estimated negative impact of $30 million based on current foreign currency exchange rates. This range represents an expected constant-currency organic sales growth of 6% to 8% over 2018 reported net sales.

Full-year 2019 adjusted-diluted EPS is expected to be in a range between $2.77 and $2.89, which includes an estimated negative impact of approximately $0.06 to full-year 2019 adjusted-diluted EPS based on current foreign currency exchange rates and excludes potential tax benefits from stock-based compensation. This assumes operating profit margin expansion of approximately 100 basis points.

This adjusted-diluted EPS guidance range assumes a full-year tax rate of 25%, which does not include potential tax benefits from stock-based compensation. We have opted not to forecast 2019 tax benefits from stock-based compensation, as they are out of the Company’s control. Any tax benefits associated with stock-based compensation that we receive in 2019 would provide a positive adjustment to our full-year EPS guidance.

Full-year 2019 capital spending is expected to be in a range between $120 million and $130 million.

Fourth-Quarter 2018 Conference Call

The Company will host a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time today. To participate on the call please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 2287302.

A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the website three hours after the live call and will be available through Thursday, February 21, 2019, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 2287302.

On February 14, 2019 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported financial results for the fourth quarter and full year ended December 31, 2018 (Press release, Quest Diagnostics, FEB 14, 2019, View Source [SID1234533345]).

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"In 2018 we grew revenues, adjusted earnings and cash from operations despite some challenges in the marketplace. Quest is well positioned once again in 2019 to deliver on our commitment to grow revenues and earnings, as our in-network status now extends to approximately 90% of commercially insured lives in the U.S.," said Steve Rusckowski, Chairman, CEO and President. "Our guidance for 2019 reflects significant reimbursement pressure offset by strong volume growth and continued execution of our Invigorate program. I am pleased to report our volumes for the year are off to a good start."

Net revenues and selling, general and administrative expenses for the three and twelve months ended December 31, 2017 have been restated to reflect the impact of new revenue recognition rules that became effective January 1, 2018 and were adopted on a full retrospective basis. Under the new rules, the company reports uncollectible balances associated with patient responsibility as a reduction in net revenues; historically these amounts were classified as bad debt expense within selling, general and administrative expenses.

For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage of net revenues, net income attributable to Quest Diagnostics, and diluted EPS, see note 2 of the financial tables attached below.

As discussed in the company’s periodic reports filed with the Securities and Exchange Commission, recording revenues and accounts receivable involves judgment and estimation. The company follows a standard process, which considers historical denial and collection experience and other factors, to estimate contractual allowances and implicit patient price concessions, and regularly updates its estimates, recording adjustments in the current period as changes in estimates. Based on this process, during the fourth quarter the company increased its reserves for revenues and accounts receivable.

Guidance for Full Year 2019

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under the accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP measures as follows: (i) for the purpose of income measures the term "adjusted" refers to operating performance measures that exclude special items such as the effect of changes in tax law on our deferred tax assets (liabilities) and reserves, restructuring and integration charges, excess tax benefit ("ETB") associated with stock-based compensation and other items; and (ii) the term "adjusted diluted EPS excluding amortization expense" represents the company’s diluted EPS before the impact of special items (described above) and amortization expense.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables attached below include reconciliations of adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "Investor." The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-424-7881 for domestic callers or 203-369-0869 for international callers; no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on February 14, 2019 until midnight Eastern Time on February 28, 2019. Anyone listening to the call is encouraged to read the company’s periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

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.