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Eagle Pharmaceuticals, Inc. Reports Fourth Quarter and Full Year 2016 Results

On March 1, 2017 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq:EGRX) reported its financial results for the three- and twelve-months ended December 31, 2016 (Press release, Eagle Pharmaceuticals, MAR 1, 2017, View Source [SID1234517910]). Highlights of and subsequent to the fourth quarter of 2016 include:

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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 Eagle’s 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,
At year end, Eagle had purchased $37 million in Eagle common stock as part of its $75 million Share Repurchase Program. Since commencing the program authorized in August 2016, Eagle has purchased more than 722,000 shares totaling approximately $48 million.
Financial Highlights:

Fourth Quarter

Total revenue for the fourth quarter of 2016 grew 346% to $81.1 million;
Product sales increased to $9.1 million compared to $2.9 million in Q4 2015;
Royalty income increased to $32.0 million compared to $0.3 million in Q4 2015;
License and other income increased to $40.0 million compared to $15 million in Q4 2015;
$52.9 million in total operating expenses during the quarter included approximately $15.6 million related to accelerated and non-recurring expenses; including $12.3 million related to R&D and $3.3 million in accelerated Sales and Marketing expense related to Ryanodex for EHS marketing activities:
R&D expense increased to $16.7 million compared to $8.8 in Q4 2015, which included $12.3 million related to accelerated and non-recurring expenses;
Sales & Marketing expense increased to $17.4 million compared to $5.6 in Q4 2015, which included $3.3 million related to accelerated spending as referenced above;
A tax benefit of $29 million was recorded during the fourth quarter driven by our reversal of the valuation allowance against the Company’s net deferred tax asset;
Q4 2016 income before income tax benefit was $28.3 million; and,
Q4 2016 net income was $57.3 million, or $3.75 per basic and $3.52 per diluted share, compared to net income of $1.2 million, or $0.08 per basic and $0.07 per diluted share in Q4 2015.
Full Year 2016

2016 revenue grew 186% to $189.5 million compared to $66.2 million in 2015;
Product sales increased to $40.6 million in 2016 compared to $13.0 million in 2015;
Royalty income increased to $99.0 million in 2016 compared to $8.3 million in 2015;
License and other income increased $49.8 million in 2016 compared to $45 million in 2015;
Full Year 2016 income before income tax benefit was $53.4 million;
Full Year 2016 net income was $81.5 million, or $5.24 per basic and $4.96 per diluted share, compared to net income of $2.6 million, or $0.17 per basic and $0.16 per diluted share in 2015; and,
Cash and cash equivalents were $52.8 million and accounts receivable were $42.2 million as of December 31, 2016.
"In 2016, we significantly enhanced Eagle’s long term value and we continue to see momentum in our business. Bendeka, for which we receive a 25% royalty, grew to 92% of the bendamustine market and has exceeded $500 million in cumulative sales since its launch in January 2016. With ten Orange-Book listed and fourteen total issued or allowed patents protecting Bendeka from 2026 through 2033, we believe the product will have a very long lifecycle," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

"With our Ryanodex for Exertional Heat Stroke and Pemetrexed NDAs now submitted to the FDA, and our continued work with fulvestrant and a potential third indication for Ryanodex for Ecstasy and methamphetamine intoxication, 2017 will be an important year for Eagle. We anticipate an FDA decision on these NDA submissions this year and are scaling our commercial organization to prepare for our first self-launched commercial product, if approved. David Pernock will lead our commercial efforts to build an internal sales organization allowing us to maximize the potential of these and future opportunities. And importantly, with multiple additional pipeline products, which we plan to discuss as the year progresses, we continue to focus on developing improved injectables for patients," added Tarriff.

"During the fourth quarter, we took advantage of our growing cash position to accelerate our research and development spend and buy back additional Eagle shares. We will continue to evaluate opportunities throughout the year to drive additional value for our shareholders," concluded Tarriff.

Fourth Quarter 2016 Financial Results

Total revenue for the three months ended December 31, 2016 was $81.1 million, as compared to $18.2 million for the three months ended December 31, 2015. A summary of total revenue is outlined below:

Three Months Ended December 31,
2016 2015

Revenue:
Product sales $ 9,080 $ 2,869
Royalty income 32,015 312
License and other income 40,046 15,000
Total revenue

81,141 18,181

Product sales increased to $9.1 million on net product sales in Bendeka, Ryanodex, docetaxel injection non-alcohol formulation, and Argatroban. Royalty income increased to $32.0 million, as a result of the launch of Bendeka in January 2016. License and other income increased to $40.0 million due to the milestone payment from Teva triggered by the CMS decision to issue a unique J-code for Bendeka.

Research and development expenses increased by $7.9 million to $16.7 million in the three months ended December 31, 2016, compared to $8.8 million in the prior year quarter. The increase was largely due to Eagle’s decision to accelerate development spending for molecules in our pipeline and additional non-recurring expenses. $12.3 million of the $16.7 million in R&D spend during the quarter was due to non-recurring expenses and those Eagle opted to accelerate.

SG&A expenses increased $11.8 million to $17.4 million in the fourth quarter of 2016 compared to $5.6 million in the three months ended December 31, 2015. Sales and marketing pre-launch related expenses accounted for the bulk of the increase as the Company prepares for the commercial launch of Ryanodex for EHS, if approved.

A tax benefit of $29 million was recorded during the fourth quarter driven by our reversal of the valuation allowance against the Company’s net deferred tax asset (primarily net operating losses). Based on current profitability and expected future profits we believe it is likely that these tax benefits will be utilized.

Net income for the fourth quarter was $57.3 million, or $3.75 per basic share and $3.52 per diluted share, compared to net income of $1.2 million, or $0.08 per basic and $0.07 per diluted share in the three months ended December 31, 2015, due to the factors discussed above.

Full Year 2016 Financial Results

Total revenue for the year ended December 31, 2016 was $189.5 million, as compared to $66.2 million for the year ended December 31, 2015. A summary of total revenue is outlined below:

Year Ended December 31,
2016 2015

Revenue:
Product sales $ 40,646 $ 12,968
Royalty income 99,040 8,259
License and other income 49,796 45,000
Total revenue 189,482 66,227

The $27.7 million increase in product sales in 2016 was driven by the launch of Bendeka and growth of Ryanodex sales. Royalty income increased by $90.8 million to $99.0 million in 2016 from $8.3 million in 2015, due to the launch of Bendeka. License and other income reflects payments received for achieving certain contractual milestones in connection with the Company’s licensing agreement with Teva.

Cost of product sales increased by $26.6 million to $34.3 million in 2016, from $7.8 million in 2015, due to the launch of Bendeka and inventory write downs. Cost of royalty increased by $13.1 million to $21.0 million in 2016, from $7.9 million in 2015 due to the launch of Bendeka.

R&D expense increased by $2.4 million in 2016 to $30.3 million compared to $27.9 million in 2015 as a result of development efforts to advance multiple product candidates, as well as $5.1 million in development spending for its fulvestrant formulation, which the Company elected to accelerate in Q4 2016.

SG&A expenses increased by $32.1 million to $52.3 million in 2016, compared to $20.2 million in 2015. This increase is related to the growth in the commercial organization, prelaunch expenses, staff additions and professional fees incurred to support expansion of the Company.

Included in operating expenses in 2016 is approximately $10 million related to stock-based compensation, a 140% increase over the same period in 2015. We estimate stock-based compensation will increase to approximately $15.5 million in 2017.

For the full year, the Company recorded a net tax benefit of $28 million. Included in this amount was a reversal of a valuation allowance which had been carried against the Company’s net deferred tax assets (primarily net operating losses).

Net income for the year ended December 31, 2016 was $81.5 million or $5.24 per basic and $4.96 per diluted share as compared to net income of $2.6 million or $0.17 per basic and $0.16 per diluted share for the year ended December 31, 2015, as a result of the factors discussed above.

Liquidity

As of December 31, 2016, the Company had $52.8 million in cash and cash equivalents; $42.2 million in receivables, with approximately $31.1 million due from Teva; and no debt.

Expense Guidance

2017 R&D expense is expected to be in the range of $31 – $35 million
2017 SG&A expense is expected to be in the range of $65 – $68 million

Sigma-Tau Pharmaceuticals, Inc. Changes Name to Leadiant Biosciences, Inc. and Reaffirms its Commitment to Rare Disease Communities

On February 28, 2017 Sigma-Tau Pharmaceuticals, Inc., a leader in the development and commercialization of medicines for patients with rare diseases, reported that the company has changed its name to Leadiant Biosciences, Inc. reaffirming the company’s continued strong commitment to the patient communities it serves (Press release, , FEB 28, 2017, https://leadiant.com/sigma-tau-pharmaceuticals-inc-changes-name-to-leadiant-biosciences-inc/ [SID1234635543]).

The announcement coincides with Rare Disease Day 2017, a global campaign to raise awareness of rare diseases and improve access to available treatments and medical representation for people, and their caregivers, whose lives are impacted by these conditions. Now in its 10th year, Rare Disease Day is an annual celebration organized by the European Organization for Rare Diseases (EURORDIS) and the National Organization for Rare Disorders (NORD). This year’s theme, With Research, Possibilities Are Limitless, underscores the importance of collaborative research in the drug-development process and recognizes the contributions of patients and families in advocating for increased investment in rare disease research.

"Rare Disease Day is the perfect time to unveil our new name and reaffirm our commitment to the study of rare diseases, which has been an integral part of our heritage dating back to 1984 when we became only the fourth company in the world to receive an Orphan Drug Designation in the U.S.," said Michael Minarich, chief executive officer, Leadiant Biosciences, Inc. "In 2017, Leadiant Biosciences will realize several important and exciting milestones in our product pipeline, as well as continuing multiple ongoing clinical trials."

For more information about the vision, mission and work of Leadiant Biosciences, Inc. visit www.leadiant.com.

Invenra and QIMR Berghofer Medical Research Institute Enter Collaboration to Discover Therapeutic An

On February 28, 2017 Invenra, Inc., a pre-clinical stage bio-pharmaceutical company focused on next-generation therapeutic human antibodies, bispecifics and antibody derivatives, and QIMR Berghofer Medical Research Institute ("QIMR Berghofer"), one of Australia’s largest, fully integrated biomedical research and development centres reported a collaboration to identify and characterize a panel of fully human therapeutic monoclonal antibodies (mAbs) against a novel target that QIMR Berghofer has identified. Financial details of the deal were not disclosed (Press release, Invenra, FEB 28, 2017, View Source [SID1234570589]).

Invenra’s proprietary platform is based on ultra-high throughput technology allowing function forward screening of full-length antibodies using Invenra’s mAbSeq technology, where antibodies can be directly and quickly interrogated in a multi-plexed fashion with a diverse set of immunotypic and biologically relevant assays. The Invenra technology allows rapid identification of high affinity mAbs with the broadest epitope coverage possible while simultaneously performing direct phenotypic screening to isolate those mAbs with the most relevant biological activity, thus leading to the election of the best lead compounds for further development.

QIMR Berghofer’s Director and CEO, Professor Frank Gannon, said, "We welcome this collaboration and look forward to working with the team at Invenra to advance the characterization and development of novel, effective cancer therapies. At QIMR Berghofer we are strongly committed to translating our research into new and better treatments, diagnostics and prevention strategies."

Roland Green, CEO and president of Invenra, said, "This collaboration is a significant milestone for Invenra as a company and another validation of our innovative technology. We are delighted to be collaborating with the outstanding team at QIMR Berghofer to identify best-in-class antibodies against their novel target. In addition, this collaboration with QIMR Berghofer fits well within our business model, whereby we are partnering with a select group of organizations while continuing to develop our own internal proprietary pipeline of therapeutic product candidates."

LIGAND EXPANDS LICENSE WITH SERMONIX TO INCLUDE WORLDWIDE RIGHTS FOR ORAL LASOFOXIFENE

On February 28, 2017 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that it has expanded its license with Sermonix Pharmaceuticals to include worldwide rights to develop and commercialize oral lasofoxifene. Ligand originally licensed the U.S. rights to oral lasofoxifene to Sermonix in February of 2015, and has now expanded the agreement to include the rest of the world (Press release, Ligand, FEB 28, 2017, View Source [SID1234532255]). Sermonix is focused on breast and ovarian cancer treatment with oral lasofoxifene, particularly an indication in the treatment of advanced Estrogen Receptor positive (ER+) endocrine-resistant breast cancer.

"Lasofoxifene is an asset with a rich heritage originating at Ligand and with a substantial set of global clinical data. This agreement with Sermonix represents an expansion of our relationship and enables further development of oral lasofoxifene on a worldwide basis," said John Higgins, Chief Executive Officer of Ligand Pharmaceuticals. "This amendment includes an upfront payment, additional commercial milestones and 6% to 10% royalties on ex-US sales and is consistent with our shots-on-goal business model of partnering the development of our assets to create a robust pipeline with limited required R&D spending by Ligand."

About Lasofoxifene and Ligand’s Lasofoxifene Partnerships

Lasofoxifene was discovered through a research collaboration between Ligand and Pfizer that began in 1991. The oral, 0.5 mg form of lasofoxifene tartrate was developed by Pfizer under the trade name Fablyn, and progressed through regulatory approval in the EU. After Pfizer acquired Wyeth and its drug Conbriza (bazedoxifene), a similar SERM program, rights to all forms of lasofoxifene reverted to Ligand in 2011. In 2013 Ligand licensed lasofoxifene to Azure Biotech for the development of a novel formulation targeting an underserved market in women’s health. Also in 2013, Ligand licensed to Ethicor Pharmaceuticals Ltd rights to manufacture and distribute oral lasofoxifene as an unlicensed medicinal product in the European Economic Area, Switzerland and the Indian Subcontinent. Ligand and Ethicor mutually terminated that agreement in early 2017.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

TESARO has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, TESARO, FEB 28, 2017, View Source [SID1234517905]).