On February 21, 2019 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported that it will host a conference call and audio webcast on Thursday, February 28, 2019 at 3:00 pm CET (9:00 am ET) to discuss its 2018 financial results and provide a fourth quarter business update (Press release, argenx, FEB 21, 2019, https://www.argenx.com/en-GB/news-internal/argenx-to-host-conference-call-webcast-to-report-fourth-quarter-business-update-and-full-year-2018-financial-results-on-february-28-2019/30213/ [SID1234533546]).

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To participate in the conference call, please select your phone number below and use the confirmation code 9795988. The webcast may be accessed on the homepage of the argenx website at www.argenx.com or by clicking here.

A replay of the webcast will also be available at the argenx website.

Dial-in numbers:

Please dial in 5–10 minutes prior to 3 p.m. CET/ 9 a.m. ET using the number and conference ID below.

Confirmation Code: 9795988

Belgium +32 (0)2 400 9874

Belgium 0800 48740

France +33 (0)1 767 00794

France 0805 103028

Netherlands +31 (0)20 714 3545

Netherlands 0800 0249557

United Kingdom +44 (0)844 571 8892

United Kingdom 0800 376 7922

United States +1 (631) 510 7495

United States +1 (866) 966 1396

A question and answer session will follow the presentation of the results. Go to www.argenx.com to access the live audio webcast. The archived webcast will also be available (90 days) for replay shortly after the close of the call from the "Downloads" section of the argenx website.

On February 21, 2019 Genomic Health, Inc. (NASDAQ: GHDX) reported financial results and business progress for the quarter and year ended December 31, 2018 (Press release, Genomic Health, FEB 21, 2019, Genomic Health Reports Record 2018 Fourth Quarter and Year-end Financial Results and Provides 2019 Financial Guidance [SID1234533545]).

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"2018 was a record year for Genomic Health. We delivered $394.1 million in revenue and non-GAAP net income of $39.7 million, exceeding expectations for the year. In December, we achieved a significant milestone delivering our one millionth Oncotype DX tests to cancer patients worldwide," said Kim Popovits, chairman of the board, chief executive officer and president of Genomic Health. "Additionally, positive results from the landmark NCI-sponsored TAILORx trial, published in June, elevated Oncotype DX to a new global standard of care for early-stage breast cancer. In 2019, we expect this momentum to continue as we increase penetration of our Oncotype DX tests both in the U.S. and key European markets and broaden global access with national reimbursement progress. We also expect to continue the expansion and diversification of our portfolio through multiple platforms and partners for longer-term growth."

Full Year 2018 Financial Results
Total revenue for 2018 was $394.1 million, compared with pre-606 adjusted revenue* of $334.0 million for 2017, an increase of 18 percent. Reported revenue was $340.8 million for 2017.

U.S. product revenue was $334.7 million for the full year 2018, compared with pre-606 adjusted revenue* of $281.6 million for 2017, an increase of 19 percent. U.S. product reported revenue was $287.4 million for 2017. U.S. invasive breast revenue from Oncotype DX Breast Recurrence Score tests was $299.4 million for 2018, compared with pre-606 adjusted revenue* of $254.0 million for 2017, an increase of 18 percent. U.S. invasive breast reported revenue was $259.7 million for 2017. U.S. prostate test revenue from Oncotype DX Genomic Prostate Score (GPS) tests was $26.8 million in 2018, compared with pre-606 adjusted revenue* of $17.9 million in 2017, an increase of 50 percent. U.S. prostate test reported revenue from GPS tests was $17.9 million in 2017.

International product revenue for 2018 was $59.4 million, compared with pre-606 adjusted revenue* of $52.0 million for 2017, an increase of 14 percent, and an increase of 12 percent on a non-GAAP constant currency basis. International product reported revenue was $53.1 million for 2017.

GAAP net income was $25.7 million, or $0.72 and $0.68 per share on a basic and diluted basis, respectively, for 2018, an improvement of $29.6 million, compared with a net loss of $3.9 million, or $0.11 per share on a basic and diluted basis, for 2017. GAAP operating income was $23.9 million for 2018, an improvement of $30.4 million, compared with an operating loss of $6.5 million for 2017.

Non-GAAP net income was $39.7 million for 2018, an improvement of $41.3 million, compared with a $1.6 million non-GAAP net loss for 2017. Non-GAAP operating income was $38.8 million for 2018, an improvement of $41.0 million, compared with a non-GAAP operating loss of $2.2 million for 2017.

2019 Financial Guidance
"We have entered 2019 with strong momentum in our business and expect to deliver revenue growth between 11 and 14 percent and significantly greater improvement in profitability for the full year with continued operating leverage," said Brad Cole, chief financial officer of Genomic Health. "In 2019, operating margin expansion is expected to deliver net income growth between 35 and 50 percent for the year on a non-GAAP basis."

The company is providing the following guidance for the full year ending December 31, 2019:

Low

High

Revenue(1)

$ 436

$ 448

Revenue Growth

11%

14%

Net Income (GAAP) (1)

$ 48

$ 54

GAAP Diluted EPS (2)

$ 1.23

$ 1.38

Net Income (Non-GAAP) (1) (3)

$ 54

$ 60

Non-GAAP Diluted EPS (2)

$ 1.38

$ 1.54

(1)

In millions.

(2)

Based on 39 million estimated shares outstanding for Diluted EPS.

(3)

Non-GAAP net income excludes charges for clinical and commercial development milestone payments; changes in fair value of investments and acquisition fees.

Additional 2018 Full Year and Fourth Quarter Financial Results
Total revenue was $104.6 million in the fourth quarter of 2018, compared with pre-606 adjusted revenue* of $85.7 million for the fourth quarter of 2017, an increase of 22 percent. Revenue growth in the fourth quarter would have been 18 percent excluding $3.5 million to reflect ASC-606 portfolio adjustments. Reported revenue was $87.5 million in the fourth quarter of 2017.

U.S. product revenue was $88.6 million in the fourth quarter of 2018, compared with pre-606 adjusted revenue* of $72.0 million for the fourth quarter of 2017, an increase of 23 percent. U.S. product reported revenue was $73.5 million in the fourth quarter of 2017. U.S. invasive breast revenue from Oncotype DX Breast Recurrence Score tests was $79.3 million in the fourth quarter of 2018, compared with pre-606 adjusted revenue* of $64.7 million in the fourth quarter of 2017, an increase of 22 percent. U.S. invasive breast reported revenue was $66.2 million in the fourth quarter of 2017. U.S. prostate test revenue from Oncotype DX GPS tests was $7.4 million in the fourth quarter of 2018, compared with pre-606 adjusted revenue* of $5.0 million in the fourth quarter of 2017, an increase of 48 percent. U.S. prostate test reported revenue from GPS tests was $5.0 million in the fourth quarter of 2017.

International product revenue was $16.0 million in the fourth quarter of 2018, compared with pre-606 adjusted revenue* of $13.4 million for the fourth quarter of 2017, an increase of 19 percent, and a 21 percent increase on a non-GAAP constant currency basis. International product reported revenue was $13.7 million in the fourth quarter of 2017.

GAAP net income was $8.9 million, or $0.25 and $0.23 per share on a basic and diluted basis, respectively, in the fourth quarter of 2018, an improvement of $7.0 million, compared with $1.9 million, or $0.05 per share on a basic and diluted basis, in the fourth quarter of 2017. GAAP operating income was $9.4 million in the fourth quarter of 2018, an improvement of $7.3 million, compared with $2.1 million in the fourth quarter of 2017.

Non-GAAP net income was $12.4 million in the fourth quarter of 2018, an improvement of $9.5 million, compared with non-GAAP net income of $2.9 million in the fourth quarter of 2017. Non-GAAP operating income was $12.3 million in the fourth quarter of 2018, compared with a non-GAAP operating income of $3.1 million in the fourth quarter of 2017.

More than 35,530 Oncotype test results were delivered in the fourth quarter of 2018, an increase of 11 percent, compared with more than 31,990 test results delivered in the same period in 2017. Oncotype DX Breast Recurrence Score tests delivered in the U.S. grew 9 percent in the fourth quarter of 2018, compared with the same period in 2017. Oncotype DX GPS tests delivered in the U.S. grew 19 percent in the fourth quarter of 2018, compared with the same period in 2017. Oncotype DX international tests delivered grew 15 percent in the fourth quarter of 2018, compared with the same period in 2017 and represented approximately 24 percent of total test volume in the quarter.

More than 136,380 Oncotype test results were delivered for the year ended December 31, 2018, an increase of 8 percent, compared with more than 126,730 test results delivered in the same period in 2017. Oncotype DX Breast Recurrence Score tests delivered in the U.S. grew 7 percent in 2018 compared to the prior year. Oncotype DX GPS tests delivered in the U.S. grew 23 percent in 2018 compared to the prior year. Oncotype DX international tests delivered grew 4 percent in 2018 compared to the prior year and represented approximately 24 percent of total test volume in 2018.

Cash and cash equivalents and short-term marketable securities at December 31, 2018, were $209.8 million, an increase of $80.2 million compared with $129.6 million at December 31, 2017.

Recent Business Highlights

Delivered, in collaboration with physicians around the world, more than 1 million Oncotype DX tests to cancer patients worldwide since the first test was made available to patients in 2004. To date, more than 53,000 physicians across 90 countries have used Oncotype DX to optimize treatment decisions for their breast, prostate and colon cancer patients, improving outcomes and saving more than $5 billion in healthcare costs.
Expanded exclusive collaboration with Biocartis Group NV to include urology for the anticipated development of an in vitro diagnostic version of the Oncotype DX Genomic Prostate Score test on Biocartis’ Idylla platform.
The U.K.’sNational Institute for Health and Care Excellence (NICE) issued updated guidance again recommending the Oncotype DX Breast Recurrence Score test for use in clinical practice to guide adjuvant chemotherapy treatment decisions and expanding its prior recommendation to now include patients with micrometastases.
The Breast published results from a French prospective decision impact study on the real-life utilization of the Oncotype DX Breast Recurrence Score test in clinical practice, demonstrating a 36 percent reduction in chemotherapy use. Consistent with other decision impact studies worldwide, these results highlight the value and need for broader patient access in France.
Nature Partner Journals (NPJ) Breast Cancer published a new analysis of the randomized NSABP B-20 study confirming patients with Oncotype DX Breast Recurrence Score results greater than 25 receive life-saving benefit from chemotherapy, reinforcing the conclusions of the landmark TAILORx study.
Presented results from two Oncotype DX studies at the 2018 San Antonio Breast Cancer Symposium reinforcing the real-world value of the Oncotype DX Breast Recurrence Score test in optimizing treatment and outcomes in breast cancer patients regardless of age or race.
Received acceptance to present five studies at the 16thSt. Gallen International Breast Cancer Conference in March 2019.
Urology published results from a multi-center study establishing Oncotype DX as the first genomic prostate cancer test with prospective validation for predicting adverse pathology to identify patients for active surveillance.
Presented results from multiple studies in men on active surveillance at the 2019 Genitourinary Cancers Symposium demonstrating association between the Oncotype DX GPS test and adverse pathology, underscoring its value in identifying patients who will ultimately require surgery due to disease progression.
*Pre-606 Adjusted Product Revenue
Effective January 1, 2018, the company adopted the new ASC 606 accounting standard for revenue, using the modified retrospective method, which applies the new standard prospectively and does not impact prior years’ financial statements. Since the as-reported 2017 quarterly and annual financial statements will not be restated to reflect the new accounting standard, the company has provided a supplemental financial schedule in the non-GAAP tables at the end of this press release, reflecting an estimate of revenue as if the new standard had been applied to the historical 2017 product revenue portion of revenue as of January 1, 2017, referred to herein as "pre-606 adjusted revenue."

Non-GAAP Disclosure
The company makes reference in this press release to "non-GAAP operating income (loss)," which excludes 2018 expenses resulting from the restructuring charges for the cessation of the Oncotype SEQ Liquid Select test product development and commercialization activities in the first quarter of 2018, the cessation of its collaboration with Cleveland Diagnostics in the second quarter of 2018, the expenses for milestone payments to Biocartis N.V. (Biocartis) in the second and third quarters of 2018, as well as the payment to Biocartis for exercising its option to expand the collaboration to include urology in the fourth quarter of 2018. Additionally, the company references "non-GAAP net income (loss)," which also excludes fair value adjustments related to its collaborations with Biocartis and Epic Sciences, and the gain on sale of marketable securities in the first quarter of 2017. The company believes that excluding these items and their related tax effects from its financial results reflects operating results that are more indicative of the company’s ongoing operating performance while improving comparability to prior periods, and, as such, may provide investors with an enhanced understanding of the company’s past financial performance and prospects for the future. The company also considers the impact of foreign currency exchange rates on its global business as described in the constant currency table accompanying this press release. The company’s management uses such non-GAAP measures internally to evaluate and assess its core operations and to make ongoing operating decisions. This information is not intended to be considered in isolation or as a substitute for income (loss) from operations or net income (loss) information prepared in accordance with GAAP. An explanation and reconciliation of the non-GAAP financial measures to the most directly comparable GAAP financial measures is included in the tables accompanying this press release.

Conference Call Details
To access the live conference call today, February 20, 2019, at 4:30 p.m. Eastern Time via phone, please dial (877) 303-7208 from the United States and Canada, or +1 (224) 357-2389 internationally. The conference call ID is 8989205. Please dial in approximately 10 minutes prior to the start of the call. To access the live and subsequently archived webcast of the conference call, go to the Investor Relations section of the company’s website at View Source Please connect to the website at least 15 minutes prior to the presentation to allow for any software download that may be necessary.

On February 21, 2019 Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported that the Company will present at the 8th Annual SVB Leerink Global Healthcare Conference on Friday, March 1, 2019 at 10:30 a.m. EST in New York, NY (Press release, Verastem, FEB 21, 2019, View Source;p=RssLanding&cat=news&id=2388338 [SID1234533542]).

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A live webcast of the presentation will be available on the investors section of the Company’s website at www.verastem.com. An archived presentation will be available for 90 days.

On February 21, 2019 Aduro Biotech, Inc. (NASDAQ: ADRO) reported that Stephen T. Isaacs, chairman, president and chief executive officer of Aduro, is scheduled to present at the 8TH Annual SVB Leerink Global Healthcare Conference in New York, New York on Thursday, February 28, 2019 at 2:00 pm ET (Press release, Aduro Biotech, FEB 21, 2019, View Source;p=RssLanding&cat=news&id=2388383 [SID1234533541]).

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To access the live webcast and subsequent archived recording of this and other company presentations, please visit the investor section of Aduro’s website at www.aduro.com. The archived webcast will remain available for replay on Aduro’s website for 30 days.

On February 21, 2019 Emergent BioSolutions Inc. (NYSE: EBS) reported financial results for the quarter and year ended December 31, 2018 (Press release, Emergent BioSolutions, FEB 21, 2019, View Source [SID1234533538]).

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2018 FINANCIAL PERFORMANCE

(I) Quarter Ended December 31, 2018 (Unaudited)

Revenues

Total Revenues
For Q4 2018, total revenues were $270.7 million, an increase of 40% over 2017. Total revenues reflect a significant increase in product sales due to the contribution of recently acquired products.

Product Sales
For Q4 2018, product sales were $217.4 million, an increase of $55.7 million or 34% as compared to 2017. The increase primarily reflects sales of NARCAN (naloxone HCl) Nasal Spray, Vivotif (Typhoid Vaccine Live Oral Ty21a) and Vaxchora (Cholera Vaccine, Live, Oral), all acquired in October 2018.

Contract Manufacturing
For Q4 2018, revenue from the Company’s contract manufacturing operations was $26.9 million, an increase of $10.7 million or 66% as compared to 2017. The increase primarily reflects increased manufacturing services for existing commercial customers at the Company’s Camden site.

Contracts and Grants
For Q4 2018, revenue from the Company’s development-based contracts and grants was $26.4 million, an increase of $10.5 million or 66% as compared to 2017. The increase primarily reflects increased R&D activities related to certain ongoing funded development programs, most notably NuThrax (anthrax vaccine adsorbed with CPG 7909 adjuvant).

Operating Expenses

Cost of Product Sales and Contract Manufacturing
For Q4 2018, cost of product sales and contract manufacturing was $113.2 million, an increase of $46.7 million or 70% as compared to 2017. The increase primarily reflects the impact of an increase in sales of NARCAN (naloxone HCl) Nasal Spray, which was acquired in the fourth quarter of 2018, and raxibacumab, which was acquired in the fourth quarter of 2017.

Research and Development (Gross and Net)
For Q4 2018, gross R&D expenses were $52.0 million, an increase of $23.5 million or 82% as compared to 2017. The increase primarily reflects an increase in costs associated with contract development services associated with NuThrax (anthrax vaccine adsorbed with CPG 7909 adjuvant).

For Q4 2018, net R&D expense, which reflects investments made in development programs that are not currently funded in whole or in part by third-party partners and is calculated as gross research and development expenses minus contracts and grants revenue, was $25.6 million, an increase of $13.0 million or 103% as compared to 2017. The increase primarily reflects investment in process improvements related to ACAM2000, (Smallpox (Vaccinia) Vaccine, Live) at the Canton site and increased costs associated with the Phase 2 clinical trial for the FLU-IGIV program. The Q4 2018 net R&D expense was 10% of net revenue (total revenue less contracts & grants) compared to 7% of net revenue in Q4 2017.

Selling, General and Administrative
For Q4 2018, selling, general and administrative expenses were $81.0 million, an increase of $39.2 million or 94% as compared to 2017. The increase primarily reflects higher transaction and integration related costs associated with the PaxVax and Adapt Pharma acquisitions.

Amortization of Intangible Assets
The Company has elected to reclassify amortization of intangible assets for Q4 2018 from cost of product sales and contract manufacturing to amortization of intangible assets, and therefore the Q4 2017 amounts have also been reclassified to conform to the current period presentation on the Company’s consolidated statements of operations.

For Q4 2018, amortization of intangible assets was $13.3 million versus $3.9 million as compared to 2017. The increase entirely reflects higher non-cash intangible asset amortization costs associated with the PaxVax and Adapt Pharma acquisitions, which both closed in the fourth quarter of 2018.

Income Taxes
For Q4 2018, the provision for income tax expense in the amount of $7.0 million includes the impact of non-deductible acquisition transaction costs and other permanent items. The effective tax rate for Q4 2018 is not meaningful given the low level of pre-tax income for the quarter.

Net Income (Loss) & Adjusted Net Income
For Q4 2018, the Company recorded a net loss of $3.4 million, or $0.07 per diluted share, versus net income of $33.9 million, or $0.67 per diluted share, in 2017. (2)

For Q4 2018, the Company recorded adjusted net income of $38.3 million, or $0.75 per diluted share, versus adjusted net income of $37.8 million, or $0.74 per diluted share, in 2017. (1) (2)

EBITDA & Adjusted EBITDA
For Q4 2018, the Company recorded EBITDA of $36.1 million versus $65.2 million in 2017. (1)

For Q4 2018, the Company recorded adjusted EBITDA of $75.0 million versus $67.1 million in 2017. (1)

(II) Year Ended December 31, 2018 (Unaudited)

Revenues

Total Revenues
For full year 2018, total revenues were $782.4 million, an increase of $221.5 million or 39% over 2017. Total revenues reflect significant increases in both product sales due to the contribution of recently acquired products and contract development and manufacturing services revenue.

Product Sales
For full year 2018, product sales were $606.5 million, an increase of $185.0 million or 44% as compared to 2017. The increase primarily reflects a full year of sales of ACAM2000, (Smallpox (Vaccinia) Vaccine, Live) and raxibacumab, both acquired in the fourth quarter of 2017, and NARCAN (naloxone HCl) Nasal Spray, which was acquired in the fourth quarter of 2018.

Contract Manufacturing
For full year 2018, revenue from the Company’s contract manufacturing operations was $98.9 million, an increase of $30.0 million or 44% as compared to 2017. The increase primarily reflects the completion of a milestone related to the expansion of certain contract manufacturing capabilities at the Company’s Lansing site, fill/finish services provided to third parties, and increased manufacturing services for commercial customers at the Company’s Canton site.

Contracts and Grants
For full year 2018, revenue from the Company’s development-based contracts and grants was $77.0 million, an increase of $6.5 million or 9% as compared to 2017. The increase primarily reflects an increase in R&D activities related to SIAN, the Company’s drug-device combination product candidate (antidote spray device) for the treatment of known or suspected acute cyanide poisoning as well as work related to ACAM2000, (Smallpox (Vaccinia) Vaccine, Live), which was acquired in the fourth quarter of 2017.

Operating Expenses

Cost of Product Sales and Contract Manufacturing
For full year 2018, cost of product sales and contract manufacturing was $322.3 million, an increase of $134.6 million or 72% as compared to 2017. The increase primarily reflects the impact of an increase in Other product sales associated principally with a full year of sales of both ACAM2000, (Smallpox (Vaccinia) Vaccine, Live) and raxibacumab, which were acquired in the fourth quarter of 2017, and NARCAN (naloxone HCl) Nasal Spray, which was acquired in the fourth quarter of 2018.

Research and Development (Gross and Net)
For full year 2018, gross R&D expenses were $142.8 million, an increase of $45.4 million or 47% as compared to 2017. The increase primarily reflects an increase in costs associated with development programs related to the Company’s recently acquired product candidates.

For full year 2018, net R&D expense was $65.8 million, an increase of $38.9 million or 145% as compared to 2017. The increase primarily reflects investment in manufacturing development activities related to ACAM2000, (Smallpox (Vaccinia) Vaccine, Live) and the FLU-IGIV program. The full year 2018 net R&D expense was 9% of net revenue (total revenue less contracts & grants) compared to 5% of net revenue in 2017.

Selling, General and Administrative
For full year 2018, selling, general and administrative expenses were $202.5 million, an increase of $59.6 million or 42% as compared to 2017. The increase primarily reflects an increase in acquisition-related costs (transaction and integration) associated with the PaxVax and Adapt acquisitions, compensation related costs from increased headcount and share-based compensation expense, and infrastructure improvement initiatives primarily related to IT systems.

Amortization of Intangible Assets
The Company has elected to reclassify amortization of intangible assets for full year 2018 from cost of product sales and contract manufacturing to amortization of intangible assets, and therefore the 2017 amounts have been reclassified to conform to the current period presentation on the Company’s consolidated statements of operations.

For full year 2018, amortization of intangible assets was $25.0 million versus $8.6 million as compared to 2017. The increase entirely reflects higher non-cash intangible asset amortization costs associated with the PaxVax and Adapt Pharma acquisitions, which both closed in the fourth quarter of 2018.

Income Taxes
For full year 2018, the provision for income tax expense in the amount of $18.8 million includes the impact of state taxes, GILTI (Global Intangible Low Income Tax), acquisition transaction costs and other non-deductible items. These are partially offset by the benefit relating to finalizing the impact of Tax Reform and the stock option deduction, resulting in an effective tax rate of 23%.

Net Income & Adjusted Net Income
For full year 2018, the Company recorded net income of $62.7 million, or $1.22 per diluted share, versus net income of $82.6 million, or $1.71 per diluted share, in 2017. (2)

For full year 2018, the Company recorded adjusted net income of $119.6 million, or $2.33 per diluted share, versus adjusted net income of $95.7 million, or $1.90 per diluted share, in 2017. (1) (2)

EBITDA & Adjusted EBITDA
For full year 2018, the Company recorded EBITDA of $152.7 million versus $166.0 million in 2017. (1)

For full year 2018, the Company recorded adjusted EBITDA of $198.8 million versus $175.7 million in 2017. (1)

The company’s financial forecast for 2019 includes the impact of the following items:

continued deliveries of BioThrax to the Strategic National Stockpile (SNS) under the current procurement contract with the Centers for Disease Control and Prevention (CDC), (the contract and the SNS are now managed by the Office of the Assistant Secretary for Preparedness and Response (ASPR));

initial deliveries of NuThrax (anthrax vaccine adsorbed with CPG 7909 adjuvant) to the SNS following expected Emergency Use Authorization pre-approval by the U.S. Food and Drug Administration (FDA) under the company’s current development and procurement contract with the Biomedical Advanced Research and Development Authority (BARDA);

full year sales of NARCAN Nasal Spray, Vaxchora (Cholera Vaccine, Live, Oral), and Vivotif (Typhoid Vaccine Live Oral Ty21a), all of which were acquired in the fourth quarter of 2018;

completion of deliveries of ACAM2000 to the SNS under the prior contract as well as initiation of new deliveries to the SNS under the anticipated follow-on procurement contract with the ASPR;

deliveries of raxibacumab to the SNS under the current procurement contract with BARDA;

domestic and international sales of the other medical countermeasures that comprise Other Product sales;

continued CDMO services revenue;

increased Contract & Grant revenue due to anticipated increased work related to development projects funded by third parties; and

continued investment in discretionary development projects funded by the company targeting opportunities in medical countermeasures for existing and emerging infectious diseases, opioid overdose and other public health threats.

The outlook for 2019 does not include estimates for potential new corporate development or other M&A transactions.

Q1 2019 REVENUE FORECAST (Reaffirmed)
For Q1 2019, the company reaffirms its expectation of total revenues of $185 to $205 million.

FOOTNOTES

See "Reconciliation of Net Income (Loss) to Adjusted Net Income, EBITDA and Adjusted EBITDA" for a definition of terms and a reconciliation table.

See "Calculation of Diluted Earnings Per Share."

CONFERENCE CALL AND WEBCAST INFORMATION
Company management will host a conference call at 5:00 pm (Eastern Time) today, February 21, 2019, to discuss these financial results. This conference call can be accessed live by telephone or through Emergent’s website:

Live Teleconference Information:
Dial in: [US] (855) 766-6521; [International] (262) 912-6157
Conference ID: 2299983

Live Webcast Information:
Visit View Source for the live webcast feed.