On March 1, 2017 GlycoMimetics, Inc. (NASDAQ: GLYC) reported progress on its clinical development programs and its financial results for the fourth quarter and year ended December 31, 2016 (Filing, Q4/Annual, GlycoMimetics, 2016, MAR 1, 2017, View Source [SID1234517911]).

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"In 2016, GlycoMimetics made significant progress across its clinical pipeline, perhaps most significantly in the maturing data from our study of GMI-1271, an E-selectin antagonist, in acute myeloid leukemia (AML). Starting early in the year, continuing mid-year at the European Hematology Association (EHA) (Free EHA Whitepaper), and finally, in December at the 58th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, we presented results from the Phase 2 portions of this study, in both newly diagnosed and relapsed/refractory patients. The ongoing trial is expected to complete enrollment in the first half of this year. Importantly the data to date suggest a very real potential for bringing a differentiated commercial product to this vastly underserved market.

Beyond this program, we initiated two new trials in 2016, a Phase 1 clinical trial of GMI-1271 in multiple myeloma (MM), and a Phase 1 clinical trial of our next drug candidate GMI-1359, a dual antagonist of both E-selectin and CXCR4, in healthy volunteers. These accomplishments position us for significant news flow in 2017. In addition, the Phase 3 trial of rivipansel being conducted by Pfizer continues to enroll sickle cell patients with the goal of completion of enrollment in the second half of 2018," said Rachel King, GlycoMimetics’ Chief Executive Officer.

Key Operational Highlights for the Fourth Quarter of 2016:

·

At the ASH (Free ASH Whitepaper) Annual Meeting in San Diego held in December 2016, GlycoMimetics presented results from its Phase 1/2 clinical trial of GMI-1271, in which high rates of remission and favorable tolerability were observed among AML patients in both arms of the trial. In the Phase 1/2 clinical trial, clinicians are studying the use of GMI-1271 along with chemotherapy. For a total of 33 study participants with relapsed or refractory disease in one arm of the trial, the complete response (CR) rate was 45 percent. For 11 newly diagnosed study participants 60 or more years of age in the




second arm of the trial, the CR rate was 73 percent. All study participants evaluated as of the ASH (Free ASH Whitepaper) meeting who had responded had complete remissions; there were no patients observed who responded with incomplete count recoveries. In addition, in elderly, newly diagnosed patients evaluated as of the date of the ASH (Free ASH Whitepaper) meeting, the 60-day mortality rate was zero for those receiving intensive induction chemotherapy plus GMI-1271.

·

GlycoMimetics continues to recruit and dose patients in the Phase 2 portion of its clinical study evaluating GMI-1271 in AML in both newly diagnosed and relapsed/refractory patients at eight active sites in the United States, Ireland and Australia. GMI-1271 has received fast track designation from the US Food & Drug Administration (FDA) for the treatment of AML, and GlycoMimetics plans to continue to engage with the FDA to discuss clinical and manufacturing planning as the program progresses.

·

GlycoMimetics continues enrollment in a Phase 1 clinical trial of GMI-1271 for MM, which enrolled the first patient in September 2016. The multi-center, open-label dose escalation trial, which has begun in Ireland, is designed to measure the efficacy, safety and pharmacokinetics of GMI-1271 in combination with chemotherapy among patients who have been diagnosed with MM and have not responded well to standard chemotherapy.

·

GlycoMimetics completed dosing in a Phase 1 clinical trial of GMI-1359 in healthy volunteers. GMI-1359 is a small molecule drug candidate that simultaneously inhibits both E-selectin and CXCR4. In this first-in-human trial, volunteer participants received a single injection of GMI-1359 and were evaluated for safety, tolerability, pharmacokinetics and pharmacodynamics over 16 days. The randomized, double-blind escalating dose study was conducted at a single site in the United States.

Fourth Quarter 2016 Financial Results:

·

Cash position: As of December 31, 2016, GlycoMimetics had cash and cash equivalents of $40.0 million as compared to $46.8 million as of December 31, 2015.

·

Revenue: The company’s revenue for the year ended December 31, 2016 was not material. The revenue recorded in the year ended December 31, 2015 was due to a $20.0 million non-refundable milestone payment from Pfizer triggered upon the dosing of the first patient in the Phase 3 clinical trial of rivipansel. There were no milestone or royalty payments from Pfizer during the year ended December 31, 2016.






·

R&D Expenses: The company’s research and development expenses decreased to $6.1 million for the quarter ended December 31, 2016 as compared to $7.0 million for the fourth quarter of 2015. Research and development expenses similarly decreased by $1.8 million to $23.3 million for the year ended December 31, 2016, from $25.1 million in the year ended December 31, 2015. During the year ended December 31, 2016, there was an increase in the costs associated with the clinical development for GMI-1271 and GMI-1359, offset by a year-over-year decrease in expenses related to manufacturing and process development for GMI-1271.

·

G&A Expenses: The company’s general and administrative expenses increased to $2.3 million for the quarter ended December 31, 2016 as compared to $2.0 million for the fourth quarter of 2015. General and administrative expenses for the year ended December 31, 2016 increased to $8.7 million as compared to $7.8 million in the prior year. These increases were primarily due to increased labor-related costs and stock-based compensation expense.
·
Shares Outstanding: Shares outstanding as of December 31, 2016 were 23,250,023.

About GMI-1271

GMI-1271 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. Preclinical research points to the drug’s potential role in moving cancerous cells out of the protective environment of the bone marrow where they hide and escape the effects of chemotherapy. In preclinical studies using animal models of AML, the results of which were presented at ASH (Free ASH Whitepaper) meetings, GMI-1271 was also associated with a reduction of chemotherapy-induced neutropenia and chemotherapy-induced mucositis.

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:

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

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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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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