On October 30, 2018 PharmaMar Group (MSE: PHM) reported total revenues of €133 million in the first nine months of 2018 (Press release, PharmaMar, OCT 30, 2018, View Source [SID1234530397]). This figure represents an increase of 7% with respect to the same period of the previous year. Oncology sales in the first nine months of the year totaled €57.4 million, compared to €64.6 million in the same period of 2017. This difference is mainly due to two factors: first, the effect of the sale of Yondelis raw materials to our partners Janssen Products and Taiho Pharmaceutical, of which €2.5 million were sold in 2017; and second, the erosion of Yondelis prices in some European countries. Revenue from royalties and licenses and other development agreements totaled €27 million in the first nine months of 2018, compared to €11 million in the same period last year. This increase is due to the recognition in the income statement of €15 million as a result of the early termination of the license agreement of Chugai Pharmaceuticals Co., in 2018. This termination also generated revenues of €3 million. Sales in the consumer chemicals sector in the first nine months of 2018 were €44.6 million, an increase of 1.7% over the same period last year (*).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

R&D expenditure through the end of the third quarter of 2018 was €57 million, compared to €56.5 million in the first nine months of 2017. In July, PharmaMar reached the target recruitment of 600 patients for the Phase III ATLANTIS trial with Zepsyre (lurbinectedin) in combination with doxorubicin compared to topotecan or CAV for the treatment of relapsed small-cell lung cancer, the results of which are expected by the end of 2019. Also with regard to lurbinectedin, for the treatment of relapsed small-cell lung cancer, an open label monotherapy phase II trial is being
carried out, the preliminary results of which were presented in June 2018 at the ASCO (Free ASCO Whitepaper) congress in Chicago. We anticipate target enrolment of 100 being reached this quarter with data reading out in the first half of 2019.

In addition, with regard to Sylentis, the HELIX phase III trial in dry eye disease has recently completed recruitment.
As a result, the Group’s adjusted EBITDA for the first nine months of 2018 was €2.2 million compared to € -6.0(*) million in the same period of the previous year and the Group recorded an attributable net profit of €5 million compared to a loss of € -14 million in the same period of the previous year. *In order to make both periods comparable, the results to September 2017 have been adjusted taking into account the discontinued operation due to the sale of Xylazel announced on September 20, 2018.

Legal warning
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction….

On October 3o, 2018 Allergan plc (NYSE: AGN) reported its third quarter 2018 performance (Press release, Allergan, OCT 30, 2018, View Source [SID1234530580]). Total third quarter 2018 GAAP net revenues were $3.91 billion, a 3.0 percent decrease from the prior year quarter.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

THIRD QUARTER 2018

Executive Commentary

"Allergan’s performance in the third quarter of 2018 highlights the momentum in our business and our focus on execution. We continued to deliver solid results in the third quarter, driven by double-digit growth from many of our key promoted brands, led by BOTOX Therapeutic and Cosmetic, JUVÉDERM, and VRAYLAR," said Brent Saunders, Chairman and CEO of Allergan. "We also maintained momentum in the R&D pipeline with achievements of significant milestones for key programs including cariprazine in bipolar depression, ubrogepant in acute migraine and abicipar in age-related macular degeneration."

"Despite the 3.0 percent decline in net revenue driven primarily by loss of exclusivity on some brands, our core business, representing nearly 90 percent of our total revenues, grew 5.9 percent versus prior year or 7.4 percent excluding foreign exchange. Allergan also maintained strong operating margins and grew non-GAAP performance net income per share. Our business continues to generate robust cash flows, and we are maintaining a disciplined approach to capital allocation – with a strong balance sheet, strategic growth investments and capital returns to our shareholders," added Saunders. "With this strong momentum in the business and based on our revised expectations for RESTASIS, we increased our full-year 2018 guidance for net revenue and non-GAAP performance net income per share."

"I am proud of what our team has accomplished this year and excited about our potential to create more value for patients, employees and shareholders for many years to come."

Third Quarter 2018 Performance

GAAP operating income in the third quarter 2018 was $257.5 million, including the impact of amortization. Non-GAAP operating income in the third quarter of 2018 was $1.91 billion, a decrease of 3.2 percent versus the prior year quarter, impacted by lower revenues as operating margin remained stable.

Operating Expenses

Total GAAP Selling, General and Administrative (SG&A) Expense was $1.04 billion for the third quarter 2018, a decrease of 10.7 percent from the prior year quarter. Total non-GAAP SG&A expense was $1.03 billion for the third quarter 2018, a decrease of 6.2 percent from the prior year period, driven primarily by a reduction in selling and marketing spending, including the impact of previous restructurings, as well as more favorable foreign exchange compared with the prior year quarter. GAAP R&D investment for the third quarter of 2018 was $424.2 million, compared to $442.6 million in the third quarter of 2017. Non-GAAP R&D investment for the third quarter 2018 was $393.7 million, compared to $405.3 million in the prior year quarter, in part due to reprioritization of R&D programs.

Amortization, Other Income (Expense) Net, Tax and Capitalization

Amortization expense for the third quarter 2018 was $1.59 billion, compared to $1.78 billion in the third quarter of 2017. GAAP other income (expense), net of $130.0 million in the three months ended September 30, 2018 was primarily attributed to a gain on the divestiture of the Company’s Medical Dermatology business sold to Almirall on September 20, 2018. The Company’s GAAP tax rate was 120.5 percent in the third quarter 2018. The Company’s non-GAAP adjusted tax rate was 14.2 percent in the third quarter 2018. As of September 30, 2018, Allergan had cash and marketable securities of $1.21 billion and outstanding indebtedness of $23.58 billion. The Company repurchased $1.76 billion aggregate principal amount of its debt in the third quarter of 2018. It expects to conduct one or more financing transactions in the fourth quarter, subject to market conditions, that are expected, together with any additional repurchases during the fourth quarter, to reduce its outstanding debt on a net basis by at least $750 million.

THIRD QUARTER 2018 BUSINESS SEGMENT RESULTS

U.S. Specialized Therapeutics

U.S. Specialized Therapeutics net revenues were $1.71 billion in the third quarter of 2018 compared to $1.72 billion in the prior year quarter. Growth in BOTOX Therapeutic and Medical Aesthetics, including BOTOX Cosmetic and ALLODERM, was offset in part by a decline in RESTASIS due to lower net pricing, demand and trade inventory levels, as well as decreased revenues in Medical Dermatology due to generic pressure prior to divestiture. Segment gross margin for the third quarter of 2018 was 91.6 percent, impacted by RESTASIS. Segment contribution for the third quarter 2018 was $1.20 billion.

Medical Aesthetics

Facial Aesthetics
BOTOX Cosmetic net revenues rose 13.9 percent in the third quarter of 2018 from the prior year quarter to $216.0 million.
JUVÉDERM Collection (defined as JUVÉDERM, VOLUMA and other fillers) net revenues in the third quarter of 2018 were $127.2 million, an increase of 10.0 percent versus the prior year quarter.
Regenerative Medicine
ALLODERM net revenues in the third quarter of 2018 grew 25.1 percent from the prior year quarter to $105.8 million.
Body Contouring
CoolSculpting net revenues (including both CoolSculpting Systems/Applicators and Consumables) in the third quarter of 2018 were $84.9 million, compared to $83.4 million in the prior year quarter.
Neurosciences & Urology

BOTOX Therapeutic net revenues in the third quarter of 2018 were $407.4 million, an increase of 10.4 percent versus the prior year quarter.
Eye Care

RESTASIS net revenues in the third quarter of 2018 were $298.0 million, a decrease of 18.8 percent versus the prior year quarter.
ALPHAGAN/COMBIGAN net revenues in the third quarter of 2018 were $95.4 million compared with $92.7 million in the prior year quarter.
OZURDEX net revenues in the third quarter of 2018 increased 16.3 percent from the prior year quarter to $28.6 million.
U.S. General Medicine

U.S. General Medicine net revenues in the third quarter of 2018 were $1.38 billion, a decrease of 7.8 percent versus the prior year quarter, impacted by lower revenues from NAMENDA XR and ESTRACE due to generic competition, offset by growth from VRAYLAR, Lo LOESTRIN and LINZESS. Segment gross margin for the third quarter of 2018 was 84.1 percent. Segment contribution for the third quarter 2018 was $890.8 million.

Central Nervous System

VRAYLAR net revenues rose 72.1 percent in the third quarter of 2018 from the prior year quarter to $138.0 million.
VIIBRYD/FETZIMA net revenues in the third quarter of 2018 were $88.5 million, compared to $86.5 million in the prior year quarter.
NAMENDA XR net revenues in the third quarter of 2018 were $16.2 million, versus $114.3 million in the prior year quarter, impacted by loss of patent exclusivity for NAMENDA XR in February 2018.
Gastrointestinal, Women’s Health & Diversified Brands

LINZESS net revenues in the third quarter of 2018 were $204.8 million, an increase of 7.3 percent versus the prior year quarter.
Lo LOESTRIN net revenues in the third quarter of 2018 were $141.5 million, an increase of 17.9 percent versus the prior year quarter.
BYSTOLIC/BYVALSON net revenues in the third quarter of 2018 were $151.2 million, compared to $164.2 million in the prior year quarter.
International

International net revenues in the third quarter of 2018 were $821.6 million, an increase of 7.8 percent versus the prior year quarter excluding foreign exchange impact, driven by growth in Facial Aesthetics and BOTOX Therapeutic. International net revenues were negatively impacted by a recall of OZURDEX in certain international markets. Excluding this impact, International net revenues would have grown by 11.8% excluding foreign exchange impact. Segment gross margin for the third quarter of 2018 was 84.1 percent, also impacted by OZURDEX. Segment contribution was $449.8 million.

Facial Aesthetics

BOTOX Cosmetic net revenues in the third quarter of 2018 were $163.4 million, an increase of 32.5 percent versus the prior year quarter excluding foreign exchange impact.
JUVÉDERM Collection net revenues in the third quarter of 2018 were $138.6 million, an increase of 16.9 percent versus the prior year quarter excluding foreign exchange impact.
Eye Care

LUMIGAN/GANFORT net revenues in the third quarter of 2018 were $94.8 million, an increase of 7.4 percent versus the prior year quarter excluding foreign exchange impact.
OZURDEX net revenues in the third quarter of 2018 were $25.8 million compared to $50.2 million in the prior year quarter.
Botox Therapeutic

BOTOX Therapeutic net revenues in the third quarter of 2018 were $92.9 million, an increase of 16.5 percent versus the prior year quarter excluding foreign exchange impact.
PIPELINE UPDATE

Allergan R&D continues to deliver on its pipeline. Key development highlights in the third quarter of 2018 included:

Regulatory Milestones & Clinical Updates

Allergan announced the completion of two positive safety studies of ubrogepant for the acute treatment of migraine. The first study (UBR-MD-04) evaluated the long-term safety and tolerability of ubrogepant (50 mg and 100 mg) compared to usual care for the acute treatment of migraine in adults for one year. The second study (3110-105-002) evaluated the hepatic safety and tolerability of ubrogepant 100 mg compared to placebo in healthy study participants over eight weeks. Based on the completion of these safety studies for ubrogepant and previously reported efficacy and safety results from the ubrogepant ACHIEVE I (UBR-MD-01) and ACHIEVE II (UBR-MD-02). studies, Allergan will submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) by the first quarter of 2019.
Allergan announced the FDA has accepted for review the Company’s supplemental New Drug Application (sNDA) for VRAYLAR (cariprazine), seeking to expand the indication to include the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults. The sNDA is supported by data from three pivotal trials, in each of which cariprazine demonstrated greater improvement than placebo for the change from baseline to week 6 on the Montgomery Asberg Depression Rating scale total score.
Allergan announced that the FDA has granted Fast Track designation for AGN-241751, an investigational new treatment for Major Depressive Disorder. AGN-241751 is a novel, oral NMDA modulator in Phase 2 development.
Allergan and Molecular Partners announced two positive Phase 3 clinical trials on Abicipar for the treatment of neovascular age-related macular degeneration. The two identical studies demonstrated that both the 8-week and 12-week treatment regimens met the pre-specified primary endpoint of non-inferiority to Ranibizumab. The Biologics License Application (BLA) filing for Abicipar is planned for the first half of 2019, pending a pre-BLA meeting. Allergan continues to expect results from MAPLE trial using its further optimized formulation in the first half of 2019.
Allergan announced positive results in Phase 2b clinical trials for Brimonidine DDS for geographic atrophy secondary to age-related macular degeneration. The BEACON study evaluated the safety and efficacy of the intravitreal implant and found that Brimonidine DDS significantly reduced mean geographic atrophy area growth at 24 and 30-months. Allergan plans to initiate Phase 3 in the second half of 2019.
Allergan received a Complete Response Letter from the FDA in response to the NDA for ulipristal acetate for the treatment of abnormal uterine bleeding in women with uterine fibroids. The agency cited safety concerns regarding ESMYA post-marketing reports outside the United States. Allergan plans to meet with the FDA by the end of 2018 to discuss their comments and next steps.
Allergan’s CoolSculpting treatment received FDA clearance to treat the submandibular area below the jawline. In addition, the FDA clearance was expanded to include patients with a BMI of up to 46.2 when treating the submental and submandibular areas. This clearance makes CoolSculpting the first and only nonsurgical fat reduction treatment to contour the area below the jawline and improve the appearance of lax tissue in conjunction with submental fat treatments.

THIRD QUARTER 2018 CONFERENCE CALL AND WEBCAST DETAILS

Allergan will host a conference call and webcast today, Tuesday, October 30, at 8:30 a.m. Eastern Time to discuss its third quarter 2018 results. The dial-in number to access the call is U.S./Canada (877) 251-7980, International (706) 643-1573, and the conference ID is 2759968. A replay of the conference call will also be available beginning approximately two hours after the call’s conclusion and will remain available through 11:30 p.m. Eastern Time on November 30, 2018. The replay may be accessed by dialing (855) 859-2056 or (404) 537-3406 and entering the conference ID 2759968.

To access the live webcast, please visit Allergan’s Investor Relations website at View Source;. A replay of the webcast will also be available

On October 30, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it has licensed its ENHANZE drug-delivery technology to Roche for exclusive development of a new undisclosed clinical stage therapeutic target, with an option to select two additional targets within four years (Press release, Halozyme, OCT 30, 2018, View Source [SID1234530358]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Under terms of the agreement, Halozyme will receive an upfront fee of $25 million with the potential to earn additional payments of up to $160 million to $165 million per target subject to achievement of specified development, regulatory and sales-based milestones. Additionally, Halozyme will receive a nomination fee for each of the two additional new target nominations. Halozyme will also receive mid-single digit royalties on sales of commercialized products. The company expects to recognize the initial $25 million payment in the fourth quarter of 2018.

"I am delighted to announce another further expansion of our long-term relationship with Roche, covering the selection of these three new targets," said Dr. Helen Torley, president and CEO. This agreement is a strong illustration of our strategy to unlock and grow ENHANZE value through supporting partners in advancing more promising targets into the clinic through the expansion of existing agreements and the addition of new ones."

The Halozyme/Roche relationship dates back to the original global collaboration and licensing agreement for the ENHANZE technology signed in 2006. Under this agreement, Roche developed Rituxan SC ex-U.S., Rituxan Hycela in the U.S., Herceptin SC ex-U.S., is awaiting an FDA action date in 2019 for Herceptin SC in the U.S., and is conducting a Phase 3 study for the fixed dose combination of Perjeta/Herceptin SC. In addition, Roche is in Phase 1 testing with an undisclosed target. More recently, in 2017, the relationship expanded to include the right to evaluate an additional target with ENHANZE.

The Halozyme ENHANZE technology is based on a proprietary recombinant human hyaluronidase enzyme (rHuPH20) that temporarily degrades hyaluronan — a glycosaminoglycan or chain of natural sugars in the body — to aid in the dispersion and absorption of other injected therapeutic drugs. For Halozyme partners, this technology may allow for more rapid delivery of injectable medications through subcutaneous delivery.

About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

On October 30, 2018 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported its preliminary financial results and its Board of Directors has approved a new stock repurchase program providing for the repurchase of up to an aggregate of $150 million of Eagle’s common stock, consisting of (i) up to $50 million in repurchases pursuant to an accelerated share repurchase ("ASR") transaction with JPMorgan Chase Bank, National Association ("JP Morgan") and (ii) up to $100 million in additional repurchases (Press release, Eagle Pharmaceuticals, OCT 30, 2018, View Source [SID1234530375]). This reflects the Company’s conviction in its business strategy.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

The specific number of shares to be repurchased is based on the average of the daily volume weighted average share prices of the Company’s common stock, less a discount, during the term of the accelerated share repurchase program.

"Based upon our long-term earnings projections and value of our pipeline, Eagle has decided to execute a $50 million ASR. At yesterday’s closing price, this would represent approximately 6% of the Company’s outstanding shares. Upon completion of this share repurchase, Eagle will have bought back a total of approximately $154 million of its stock since its IPO in 2014," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

"We believe this is a good use of our cash to benefit shareholders and remain committed to expanding our products and pipeline over the long-term. The stock repurchase reflects the commitment of the Board and management to enhance shareholder return," added Tarriff.

Under the terms of the agreement, Eagle will pay $50 million to JP Morgan on November 1, 2018, and receive 702,988 shares, representing approximately 80% of the notional amount of the ASR, based on the closing price of $56.90 on October 29, 2018. Upon settlement of the ASR, the final number of shares repurchased will be trued up based on the average of the daily volume weighted average share prices of the Company’s common stock, less a discount, during the term of the accelerated share repurchase program. Eagle expects the ASR to be completed in the fourth quarter of 2018. As of September 30, 2018, the Company had 14.9 million common shares outstanding.

The Company intends to use cash on hand to fund the ASR program. As of September 30, 2018, cash and cash equivalents were $91 million, accounts receivable was approximately $78 million, and debt was $45 million.

The Company also announced preliminary financial results

Q3 2018 preliminary revenue is expected to be $51 million;

Q3 2018 preliminary net income is expected to be $14 million, or $0.94 per basic and $0.91 per diluted share; and

Q3 2018 preliminary Adjusted Non-GAAP net income is expected to be approximately $18 million or $1.22 per basic and $1.18 per diluted share

On October 30, 2018 Incyte Corporation (Nasdaq:INCY) reported 2018 third quarter and nine month financial results and provides a status update on the Company’s development portfolio (Press release, Incyte, OCT 30, 2018, View Source [SID1234530360]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

"The total number of patients taking Jakafi continues to increase in both approved indications, and we have raised the lower end of our full year revenue guidance," stated Hervé Hoppenot, Chief Executive Officer, Incyte. "We see a remarkable set of opportunities in the coming months from our late-stage development portfolio, including both ruxolitinib and itacitinib as potential treatments for certain patients with GVHD. Recent data from pemigatinib and capmatinib, which are both Incyte-invented molecules, as well as from ruxolitinib cream, all serve to highlight the quality of Incyte’s drug discovery capabilities, and the value created by our R&D efforts."

Portfolio Update

Oncology – key highlights

The sNDA seeking approval of ruxolitinib for the treatment of steroid-refractory acute GVHD has been accepted for Priority Review by the U.S. Food and Drug Administration (FDA), and was given a Prescription Drug User Fee Act (PDUFA) date of February 24, 2019. The application for approval was based on the successful REACH1 trial, additional results from which are expected to be presented in the fourth quarter of 2018. Planning is already underway for the U.S. launch should ruxolitinib be approved in this new indication.

The global Phase 3 GRAVITAS-301 trial of itacitinib as a treatment for patients with newly-diagnosed acute GVHD is enrolling well, and results are expected next year. If the GRAVITAS-301 trial is successful, Incyte expects to submit applications seeking marketing approval for itacitinib in major markets globally.

Data from the ongoing trials evaluating pemigatinib in cholangiocarcinoma and bladder cancer were recently presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. Incyte expects to submit an NDA for pemigatinib as a treatment for patients with advanced cholangiocarcinoma during 2019, and to start a Phase 3 trial for the first-line treatment of patients with cholangiocarcinoma in the coming months. Enrollment in the continuous dosing cohort of the Phase 2 trial of pemigatinib in patients with bladder cancer is now underway.

Positive data from the randomized Phase 2 trial of ruxolitinib cream in adult patients with atopic dermatitis were presented as an oral presentation at the European Academy of Dermatology and Venerology (EADV) Congress on September 13th. Incyte is planning to initiate a global, pivotal Phase 3 program in this indication.

Data from the randomized Phase 2 trial of ruxolitinib cream in patients with vitiligo are expected in 2019.

Incyte has initiated a Phase 2 trial of INCB54707, a selective JAK1 inhibitor, for the treatment of patients with hidradenitis suppurativa, an inflammatory follicular skin disease.

Lilly recently initiated a Phase 3 trial of baricitinib in patients with systemic lupus erythematosus and a Phase 2/3 adaptive design trial of baricitinib in patients with severe alopecia areata.

Novartis recently presented data from the ongoing trial of capmatinib in patients with MET exon-14 skipping mutated non-small cell lung cancer, and expects to submit an NDA for capmatinib in 2019.

The financial measures presented in this press release for the three and nine months ended September 30, 2018 and 2017 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for both revenues and expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers. Reconciliations of GAAP net income (loss) to Non-GAAP net income for the three and nine months ended September 30, 2018 and 2017 have been included at the end of this press release.

Guidance related to research and development and selling, general and administrative expenses does not include estimates associated with any potential future strategic transactions.

Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry.

Revenues For the quarter ended September 30, 2018, GAAP net product revenues of Jakafi were $348 million as compared to $304 million for the same period in 2017, representing 14 percent growth. For the nine months ended September 30, 2018, GAAP net product revenues of Jakafi were $1.0 billion as compared to $831 million for the same period in 2017, representing 21 percent growth. For the three months ended September 30, 2018, GAAP net product revenues of Iclusig (ponatinib) were $20 million as compared to $18 million for the same period in 2017. For the nine months ended September 30, 2018, GAAP net product revenues of Iclusig were $61 million as compared to $47 million for the same period in 2017.

For the quarter and nine months ended September 30, 2018, GAAP product royalties from sales of Jakavi (ruxolitinib), which has been out-licensed to Novartis outside of the United States, were $51 million and $139 million, respectively, as compared to $41 million and $104 million, respectively, for the same periods in 2017. For the quarter and nine months ended September 30, 2018, GAAP product royalties from sales of Olumiant, which has been out-licensed to Lilly globally, were $11 million and $26 million, respectively, as compared to $3 million and $5 million, respectively, for the same periods in 2017.

For the quarter and nine months ended September 30, 2018, GAAP milestone revenues were $20 million and $120 million, as compared to $15 million and $105 million, respectively, for the same periods in 2017. GAAP milestone revenues in 2018 and 2017 related to milestones earned from our collaborative partners. Non-GAAP revenues exclude milestone revenues.

For the quarter and nine months ended September 30, 2018, total GAAP revenues were $450 million and $1.4 billion, respectively, as compared to $382 million and $1.1 billion, respectively, for the same periods in 2017. Total Non-GAAP revenues for the quarter and nine months ended September 30, 2018 were $430 million and $1.2 billion, respectively, as compared to $367 million and $987 million, respectively, for the same periods in 2017.

Cost of product revenues GAAP cost of product revenues for the quarter and nine months ended September 30, 2018 was $25 million and $68 million, respectively, as compared to $22 million and $57 million, respectively, for the same periods in 2017. Non-GAAP cost of product revenues for the quarter and nine months ended September 30, 2018 was $19 million and $52 million, respectively, as compared to $17 million and $41 million, respectively, for the same periods in 2017. Non-GAAP cost of product revenues excludes the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc.

Research and development expenses GAAP research and development expenses for the quarter and nine months ended September 30, 2018 were $293 million and $894 million, respectively, as compared to $270 million and $879 million, respectively, for the same periods in 2017. The increase in GAAP research and development expenses over the prior year quarter was driven primarily by $15 million in milestone expenses related to our collaboration agreements. The increase in GAAP research and development expenses from the prior year nine month period was driven primarily by an overall increase in development costs to advance our clinical pipeline.

Non-GAAP research and development expenses for the quarter and nine months ended September 30, 2018 were $251 million and $771 million, respectively, as compared to $234 million and $590 million, respectively, for the same periods in 2017. Non-GAAP research and development expenses for the quarter and nine months ended September 30, 2018 exclude the cost of stock-based compensation of $26 million and $75 million, respectively, and upfront consideration and milestones to our collaborative partners of $15 million and $47 million, respectively. Non-GAAP research and development expenses for the quarter and nine months ended September 30, 2017 exclude the cost of stock-based compensation of $23 million and $68 million, respectively, upfront consideration and milestones paid to our collaborative partners of $0 million and $209 million, respectively, and an asset impairment charge of $12 million.

Selling, general and administrative expenses GAAP selling, general and administrative expenses for the quarter and nine months ended September 30, 2018 were $97 million and $326 million, respectively, as compared to $91 million and $269 million, respectively, for the same periods in 2017. The increase in GAAP selling, general and administrative expenses from the prior year nine month period were driven by an increase in donations to independent non-profit patient assistance organizations in the United States and additional costs related to the commercialization of Jakafi.

Non-GAAP selling, general and administrative expenses for the quarter and nine months ended September 30, 2018 were $85 million and $291 million, respectively, as compared to $80 million and $237 million, respectively, for the same periods in 2017. Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation.

Change in fair value of acquisition-related contingent consideration GAAP change in fair value of acquisition-related contingent consideration for the quarter and nine months ended September 30, 2018 was expense of $5 million and $19 million, respectively, as compared to a benefit of $16 million and $2 million respectively, for the same periods in 2017.

Unrealized gain (loss) on long term investments GAAP unrealized loss on long term investments for the quarter and nine months ended September 30, 2018 was $10 million and $22 million, respectively, as compared to a gain of $23 million and a loss of $2 million, respectively, for the same periods in 2017. The unrealized gain (loss) on long term investments for the quarter and nine months ended September 30, 2018 represents the fair market value adjustments of the Company’s investments in Agenus, Calithera, Merus, and Syros.

Expense related to senior note conversions GAAP expense related to senior note conversions for the nine months ended September 30, 2017 was $55 million related to the conversions of certain of our 2018 and 2020 convertible senior notes.

Net income (loss) GAAP net income for the quarter ended September 30, 2018 was $29 million, or $0.14 per basic and diluted share, as compared to a net income of $36 million, or $0.17 per basic and diluted share for the same period in 2017. GAAP net income for the nine months ended September 30, 2018 was $40 million, or $0.19 per basic and diluted share, as compared to a net loss of $164 million, or $0.81 per basic and diluted share for the same period in 2017.

Non-GAAP net income for the quarter ended September 30, 2018 was $83 million, or $0.39 per basic and $0.38 per diluted share, as compared to Non-GAAP net income of $41 million, or $0.20 per basic and $0.19 per diluted share for the same period in 2017. Non-GAAP net income for the nine months ended September 30, 2018 was $137 million, or $0.64 per basic and $0.63 per diluted share, as compared to Non-GAAP net income of $127 million, or $0.63 per basic and $0.61 per diluted share for the same period in 2017.

Cash, cash equivalents and marketable securities position As of September 30, 2018, cash, cash equivalents and marketable securities totaled $1.4 billion as compared to $1.2 billion as of December 31, 2017.

(1)Adjusted to exclude the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc.
(2)Adjusted to exclude the estimated cost of stock-based compensation, upfront consideration of approximately $12 million related to the Syros collaboration, upfront consideration of $15 million related to the BMS license agreement, milestone payments of $10 million related to the Agenus collaboration and milestone payments of $10 million related to the MacroGenics collaboration.
(3)Adjusted to exclude the estimated cost of stock-based compensation.
(4)Adjusted to exclude the change in fair value of estimated future royalties relating to sales of Iclusig in the licensed territory relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc.

Future Non-GAAP financial measures may also exclude upfront and ongoing milestones relating to third-party collaboration partners, impairment of goodwill or other assets, changes in the fair value of equity investments in our collaboration partners, non-cash interest expense related to the amortization of the initial discount on our 2018 and 2020 Senior Notes and the impact on our tax provision of discrete changes in our valuation allowance position on deferred tax assets.

Conference Call and Webcast Information

Incyte will hold a conference call and webcast this morning at 8:00 a.m. EDT. To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13683637.

If you are unable to participate, a replay of the conference call will be available for 30 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference identification number, 13683637.

The conference call will also be webcast live and can be accessed at www.incyte.com in the Investors section under "Events and Presentations