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Exhibit 99.1
For Immediate Release
Eagle Pharmaceuticals, Inc. Reports Fourth Quarter and Full Year 2016 Results
Bendeka® market share grew to 92%
Bendeka reaches $500 million in cumulative sales in Q1 2017, triggering $25 million milestone
2016 Revenue grew 186% to $189.5 million
Q4 2016 income before tax benefit grew to $28.3 million, including $15.6 million of accelerated and non-recurring expenses
Q4 2016 EPS grew to $3.75 per basic and $3.52 per diluted share
Full Year 2016 income before tax benefit grew to $53.4 million
Full Year 2016 EPS grew to $5.24 per basic and $4.96 per diluted share
Q4 2016 included $29 million of income tax benefit on release of tax valuation allowance
WOODCLIFF LAKE, N.J. March 1, 2017Eagle Pharmaceuticals, Inc. (Eagle or the Company) (Nasdaq: EGRX) today announced its financial results for the three- and twelve-months ended December 31, 2016. Highlights of and subsequent to the fourth quarter of 2016 include:
Business Highlights:
· Bendeka total market share rose to 92%, as of February 24, 2017;
· Bendeka achieves $500 million in cumulative sales, triggering $25 million sales milestone from Teva in Q1 2017;
· Eight new patents allowed by the U.S. Patent and Trademark Office for Eagles Bendeka portfolio bringing the total to 14 issued or allowed, with 11 issued to-date and ten listed in the Orange Book;
· The Centers for Medicare & Medicaid Services (CMS) established a unique J-Code (J9034) for Bendeka effective January 1, 2017 triggering a $40 million milestone payment from Teva in Q4 2016;
· Ryanodex® sales increased to $3.9 million during the fourth quarter;
· Completed NDA submission for Ryanodex for Exertional Heat Stroke (EHS) and requested Priority Review;
· NDA for Pemetrexed Injection for non-small cell lung cancer and mesothelioma accepted for filing; PDUFA target date of October 30, 2017;
· Entered the biologics sector with the acquisition of Arsia Therapeutics, now renamed Eagle Biologics;
· Board member, David Pernock, joined Eagle management as President and Chief Commercial Officer; and,
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Eagle Pharmaceuticals, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2017 10-K Annual Report includes:
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Moreover, insurance coverage is becoming increasingly expensive and in the future we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due to liability.
As described above, under the terms of the Cephalon License, the Company received an upfront cash payment of $30 million, received a milestone payment of $15 million, received $40 million milestone upon receipt of the J-code and is eligible to receive up to $25 million in an additional milestone payment on its commercial partner reaches a key sales milestone.
Any adverse outcome in these types of matters could result in one or more generic versions of our products being launched before the expiration of the listed patents, which could adversely affect our ability to successfully execute our business strategy to increase sales of our products and would negatively impact our financial condition and results of operations, including causing a significant decrease in our revenues and cash flows.
Any of these events could prevent us from achieving or maintaining market acceptance of the affected product or product candidate and could substantially increase the costs of commercializing our products and product candidates.
Moreover, because of the discount pricing typically involved with bioequivalent and, to a lesser extent, 505b2, products, patented branded products generally realize a substantially higher profit margin than bioequivalent and, to a lesser extent, 505b2, products, resulting in disproportionate damages compared to any profits earned by the infringer.
The 2007 Plan was terminated...Read more
These lawsuits could hinder our...Read more
If initiation or completion of...Read more
Additionally, under the terms of...Read more
Additionally, under the terms of...Read more
We may experience decreases in...Read more
In addition, any delay or...Read more
Future issuances of our common...Read more
If we are unable to...Read more
In addition, the incurrence of...Read more
Diluted earnings per share is...Read more
The GPOs with whom we...Read more
The loss, theft or sabotage...Read more
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For example, our product commercialization...Read more
Further, if we encounter delays...Read more
Some of our competitors have...Read more
Any of these events could...Read more
Identifying an appropriately qualified source...Read more
Our primary exposure to market...Read more
Topic 606 Revenue from Contracts...Read more
Topic 606 Revenue from Contracts...Read more
Any government investigation of alleged...Read more
An adverse result in any...Read more
Inferior internal controls could also...Read more
Regulations or guidelines suggesting the...Read more
Furthermore, the Company believes that...Read more
Furthermore, the Company believes that...Read more
Sales of a substantial number...Read more
Delays in clinical trials are...Read more
The decrease in other income...Read more
Net changes in working capital...Read more
System failures, accidents or security...Read more
Accounts receivable increased primarily due...Read more
Such characteristics could cause us,...Read more
As a result, the coverage...Read more
Although we believe that the...Read more
However, the Leahy-Smith Act and...Read more
the federal Anti-Kickback Statute, which...Read more
If the fair value of...Read more
Salary and other personnel-related expenses...Read more
Seeking foreign regulatory approval could...Read more
Eagle Pharmaceuticals Inc.s management is...Read more
In November 2013, the Companys...Read more
The number of shares available...Read more
A companys internal control over...Read more
On August 9, 2016, the...Read more
On August 9, 2016, the...Read more
On August 9, 2016, the...Read more
On August 9, 2016, the...Read more
The FDA may also require...Read more
Reimbursement by a third party...Read more
The effective date and transition...Read more
The effective date and transition...Read more
We have not identified any...Read more
Selling, general and administrative costs...Read more
Moreover, the inability to pursue...Read more
To the extent that any...Read more
for our product candidates would...Read more
Currently, we plan to register...Read more
These factors could cause the...Read more
These actions, if successful, or...Read more
These actions, if successful, or...Read more
A material weakness is a...Read more
A material weakness is a...Read more
A material weakness is a...Read more
Since our inception, we have...Read more
Provisions in our amended and...Read more
Non-compliance events that could result...Read more
In addition, SciDose royalty expense...Read more
Under the terms of the...Read more
In addition, the Company was...Read more
In addition, the Company was...Read more
The securities described above were...Read more
Royalties are recognized as earned...Read more
Royalty revenue is recognized as...Read more
Royalties are recognized as earned...Read more
If we are unable to...Read more
If our management is unable...Read more
Our significant accounting policies are...Read more
License and other revenue for...Read more
These and other market and...Read more
These requirements will be phased...Read more
Conversion could occur, upon certain...Read more
Additionally, expenses include salaries, benefits...Read more
Such litigation, and any similar...Read more
We expect our development expenses...Read more
foreign currency fluctuations, which could...Read more
The securities described above were...Read more
As our company matures, we...Read more
The Company considers all highly...Read more
If this were to occur,...Read more
Although we have internal research...Read more
Our audit included obtaining an...Read more
The commercialization of any of...Read more
Effective internal controls over financial...Read more
Other income and expense decreased...Read more
The increases resulted from an...Read more
The guidance is effective for...Read more
The guidance is effective for...Read more
The guidance is effective for...Read more
The guidance is effective for...Read more
All previously reported share and...Read more
Prior to the shipment of...Read more
Because of the numerous risks...Read more
Adjustment to recognize pro forma...Read more
Business interruptions could delay us...Read more
Sales of a substantial number...Read more
All stock-based awards granted to...Read more
The table below provides reconciliation...Read more
The amendments relate to when...Read more
provide reasonable assurance regarding prevention...Read more
The amendments relate to when...Read more
We could incur substantial costs...Read more
The Company was to receive...Read more
The new standard is effective...Read more
The new standard is effective...Read more
Third party coverage and reimbursement...Read more
Any such disagreement between us...Read more
It is possible that a...Read more
On February 13, 2015, we...Read more
This $0.1 million net decrease...Read more
If any of our current...Read more
Accordingly, competition from generic equivalents...Read more
Events giving rise to impairment...Read more
Those standards require that we...Read more
If we are unable to...Read more
The Company capitalizes and includes...Read more
the Foreign Corrupt Practices Act,...Read more
Leasehold improvements are being amortized...Read more
Current and future legislation may...Read more
Therefore, our requirement to make...Read more
If any of our third-party...Read more
Furthermore, because of the substantial...Read more
In addition, our reported financial...Read more
We expect that our selling,...Read more
We have very limited prior...Read more
share price and volume fluctuations...Read more
Although we have not currently...Read more
Selling, general and administrative expenses...Read more
Selling, general and administrative expenses...Read more
Royalty revenue increased $0.8 million...Read more
The full impact of these...Read more
In July 2015, the FASB...Read more
In July 2015, the FASB...Read more
Clinical study costs are accrued...Read more
We regard an accounting estimate...Read more
The Company recognizes revenue from...Read more
The cost of revenue increase...Read more
This increase was due to...Read more
As a result, if we...Read more
The net proceeds to us...Read more
The net proceeds to Eagle...Read more
The net proceeds from this...Read more
Research and development expenses increased...Read more
Research and development expenses increased...Read more
Officer Severance Benefit Plan incorporated...Read more
Officer Severance Benefit Plan on...Read more
Officer Severance Benefit Plan on...Read more
License and Development Agreement, by...Read more
Competitors who obtain the requisite...Read more
We may not have enough...Read more
The J-code became effective on...Read more
If we or they are...Read more
The J-code became effective on...Read more
Net changes in working capital...Read more
In each instance, revenue is...Read more
Issuance of common stock in...Read more
Issuance of common stock in...Read more
Issuance of common stock in...Read more
On October 31, 2016, the...Read more
On October 31, 2016, the...Read more
Cost of revenue increased $3.9...Read more
In addition, we plan to...Read more
Total revenue increased $0.1 million...Read more
Should any of these events...Read more
In consideration of the assets...Read more
In consideration of the assets...Read more
In consideration of the assets...Read more
In accordance with the provisions...Read more
Accounts payable and accrued expenses...Read more
An adverse decision in patent...Read more
Accounts payable and accrued expenses...Read more
Any losses or damages we...Read more
The Companys business model is...Read more
We recognize revenue from milestone...Read more
Research and development expenses incurred...Read more
Under the Share Repurchase Program,...Read more
Under the Share Repurchase Program,...Read more
Under the Share Repurchase Program,...Read more
Under the Share Repurchase Program,...Read more
If we are able to...Read more
Pending their use, we may...Read more
The Company recognizes revenue from...Read more
Additionally, this event triggered an...Read more
Additionally, this event triggered an...Read more
Additionally, this event triggered an...Read more
Additionally, this event triggered an...Read more
We are also eligible to...Read more
Accrued expenses increased primarily due...Read more
The Company is also eligible...Read more
Under the stock purchase agreement,...Read more
In December 2007, the Companys...Read more
The final rule, effective April...Read more
Recoveries of previously recognized R&D...Read more
The guidance is effective for...Read more
The guidance is effective for...Read more
Inventories increased significantly in preparation...Read more
The cost to replace the...Read more
Specifically, there have been several...Read more
However, if we are found...Read more
These costs include expenses associated...Read more
In addition, the FDAs regulations,...Read more
In addition, the market price...Read more
We expect to incur additional...Read more
Even if a potential product...Read more
or USPTO, has developed new...Read more
These investments may not yield...Read more
strengthen our tax provision review...Read more
These intangible assets were originally...Read more
These sales may also result...Read more
Upon termination of a collaboration...Read more
If securities analysts or investors...Read more
Upon termination of a collaboration...Read more
These laws may impact, among...Read more
actions taken by a partner...Read more
the perception of patients and...Read more
Landlord contribution to leasehold improvements...Read more
Any change in fair value...Read more
Adjustment to recognize incremental amortization...Read more
Selling, general and administrative expenses...Read more
Broad market and industry factors...Read more
We recognize any interest and...Read more
We recognize any interest and...Read more
We may be involved in...Read more
Any of our executive officers...Read more
The fair value of the...Read more
federal civil and criminal false...Read more
Our defense of litigation or...Read more
If we partner with a...Read more
If we are unable to...Read more
Manufacturers of drug products and...Read more
We have broad discretion in...Read more
The aggregate net proceeds received...Read more
The aggregate net proceeds received...Read more
Moreover, these rules and regulations...Read more
If we do not obtain...Read more
Acquisitions upon FDA approval and...Read more
We experienced an increase in...Read more
For public companies, the amendments...Read more
For public companies, the amendments...Read more
Switching manufacturers may involve substantial...Read more
Maintaining strong relationships with these...Read more
Royalty revenue decreased $2.4 million...Read more
Eagle Biologics platform technology enables...Read more
Non-recurring transactions costs of $0.7...Read more
The incurrence of indebtedness, including...Read more
There is no assurance that...Read more
As of December 31, 2016,...Read more
As a result of the...Read more
In that case, the trading...Read more
Such a loss of patent...Read more
Efforts to ensure that our...Read more
We, or our contract manufacturers,...Read more
There may be third-party patents...Read more
On November 4, 2015, we...Read more
Research and development expenses increased...Read more
Cost of royalty revenue increased...Read more
In the case of discounted...Read more
We may not be successful...Read more
Total revenue increased $123.3 million...Read more
Royalty revenue increased $90.8 million...Read more
License and other revenue increased...Read more
License and other revenue increased...Read more
Total revenue increased $47.1 million...Read more
Product sales increased approximately $8.4...Read more
Our definite-lived intangible assets include...Read more
The gross carrying amounts and...Read more
scope of intangible assets is...Read more
The core technology intangible assets...Read more
Furthermore, if our suppliers fail...Read more
Product candidates in later stage...Read more
Levels of market acceptance for...Read more
These terms may restrict our...Read more
These provisions may frustrate or...Read more
If Hikma had prevailed on...Read more
These estimates will be adjusted...Read more
While we have confidence in...Read more
If we encounter any disruptions...Read more
Recruiting and retaining other qualified...Read more
Our business operations and activities...Read more
If we or one of...Read more
We have obtained, and continue...Read more
Our products or product candidates...Read more
However, the failure to obtain...Read more
All shares repurchased by the...Read more
Such lawsuit, as well as...Read more
The anti-dilutive common shares equivalents...Read more
Discussions with the FDA to...Read more
If we are unable to...Read more
the federal Physician Payments Sunshine...Read more
As a result, these companies...Read more
we may be unable to...Read more
Proceeds from issuance of common...Read more
There can be no assurance...Read more
The United States and some...Read more
Regulatory requirements can vary widely...Read more
Payment for Ryanodex intangible asset...Read more
These problems include difficulties with...Read more
Net cash provided by financing...Read more
We cannot assure you that...Read more
We and our CROs are...Read more
In preparation for near-term product...Read more
We did not identify any...Read more
Financial Statements, Disclosures and Schedules
Inside this 10-K Annual Report
Material Contracts, Statements, Certifications & more
Eagle Pharmaceuticals, Inc. provided additional information to their SEC Filing as exhibits
Ticker: EGRX
CIK: 827871
Form Type: 10-K Annual Report
Accession Number: 0000827871-17-000002
Submitted to the SEC: Wed Mar 15 2017 5:22:40 PM EST
Accepted by the SEC: Wed Mar 15 2017
Period: Saturday, December 31, 2016
Industry: Pharmaceutical Preparations