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]).

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"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

On October 30, 2018 Patient growth continues across all regions (Press release, Fresenius, OCT 30, 2018, View Source [SID1234530376])

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Operating margin in North America improved to 18.5% in the third quarter
Dialysis Care revenue growth in North America of 6% (+5% at constant currency)
Decline in Care Coordination revenue following Sound divestiture
Outlook 2018 reflects lower than expected growth acceleration in Q3 and anticipation of soft business development in Q4 2018

Rice Powell, Chief Executive Officer of Fresenius Medical Care, said: "Our third quarter was affected by several developments whose combined impact on our results was greater than expected. Growth did not accelerate to the extent previously projected. We anticipate the impact from the current level of growth and less acquisitions to continue in the fourth quarter. We have identified countermeasures and have begun implementation. Fresenius Medical Care’s growth will continue."

Growth in Dialysis Care revenue

Revenue in the third quarter 2018 decreased by 6% to EUR 4,058 million (-6% at constant currency), mainly driven by the higher comparable base which included the Q3 2017 revenue contribution from Sound Inpatient Physicians ("Sound") of EUR 253 million as well as the impact from the IFRS 15 implementation ("IFRS 15") of EUR 117 million. Excluding these two effects, revenue increased by 2% on a comparable basis (+3% at constant currency), mainly driven by an increase in same market treatments in North America of 3%.

Health Care Services revenue decreased by 8% to EUR 3,258 million (-8% at constant currency), primarily driven by the two effects described above (Sound and IFRS 15). On a comparable basis, Health Care Services revenue increased by 3%, mainly driven by organic growth in Dialysis Care revenue resulting from higher volumes, partly offset by the largely anticipated revenue decline in Care Coordination. Care Coordination revenue declined by 53% to EUR 354 million (-56% at constant currency), mainly resulting from the sale of Sound and the IFRS 15 implementation. On a comparable basis, Care Coordination revenue declined by 22% (-27% at constant currency). This decline was mainly the result of the shift of calcimimetic drugs into the clinical environment and a higher prior-year revenue contribution due to the initial revenue recognition for the new 2017 ESCOs. Health Care Products revenue was flat at EUR 800 million (+1% at constant currency), mainly impacted by the difficult economic environment in certain emerging countries in the EMEA and Latin America regions. At constant currency, Dialysis Products revenue increased by 2% driven by higher sales of renal pharmaceuticals and products for acute care treatments, partially offset by lower sales of chronic hemodialysis products.

In the first nine months of 2018, revenue decreased by 8% to EUR 12,247 (-2% at constant currency), mainly driven by the effects of Sound and IFRS 15. On a comparable basis, revenue decreased by 4%, impacted by negative foreign currency effects (+3% at constant currency).

Operating income (EBIT) impacted by one-time effects

Total EBIT reached EUR 527 million in the third quarter of 2018, a decrease of 13% (-20% at constant currency). The strong decrease was mainly attributable to the higher comparable base which included the EBIT contribution from Sound of EUR 20 million. In addition, the increased provision for the FCPA related charge in the amount of EUR 75 million and the contributions to the opposition to the ballot initiatives in the U.S. of EUR 23 million (both not tax effected) as well as a EUR 10 million favourable foreign currency translation effect related to the divestitures of Care Coordination activities affected the EBIT growth. The increase of the FCPA provision reflects an understanding with the U.S. Government on the financial aspects of a potential settlement and an update of ongoing legal costs to continue settlement discussions. However, significant non-financial matters are still under discussion with the government and must be resolved to the company’s satisfaction for a settlement to occur. In addition, EBIT was negatively impacted by the difficult economic situation in certain emerging countries, including hyperinflation in Argentina. On a comparable basis, EBIT increased by 5% (+4% at constant currency).

In the first nine months of 2018, EBIT increased by 32% (+39% at constant currency). The strongest contributor to this increase was the gain related to the divestitures of Care Coordination activities. On a comparable basis, EBIT decreased by 7% (-2% at constant currency).

Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA decreased by 8% to EUR 285 million in the third quarter of 2018 (-17% at constant currency). On a comparable basis net income increased by 20% to EUR 364 million (+19% at constant currency). Based on the number of approximately 306.5 million shares (weighted average number of shares outstanding), basic earnings per share (EPS) amounted to EUR 0.93 (-8%). On a comparable basis the company generated an EPS of EUR 1.19, representing an increase of 20% (+19% at constant currency).

In the first nine months of 2018, net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA increased by 76% (+86% at constant currency) to EUR 1,557 million, mainly driven by the gain related to the divestitures of Care Coordination activities. On a comparable basis, net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA reached EUR 969 million, an increase of 10% (+16% at constant currency).

Patient growth continues across all regions

North America revenue, which represents 70% of total revenue in the third quarter of 2018, decreased by 9% to EUR 2,843 million (-11% at constant currency) and increased by 4% on a comparable basis (+1% at constant currency). Organic growth in North America was 2%.

Dialysis Care revenue increased by 6% to EUR 2,328 million (+5% at constant currency). This increase was mainly driven by an increase in organic revenue per treatment, same market treatment growth of 3% in the U.S. and contributions from acquisitions, to some extent diluted by the implementation of IFRS 15 and the effect of 1 less dialysis day. Volume growth in North America was positively impacted by a strong increase in home dialysis in the third quarter, leading to a home penetration rate in the U.S. of 12.4%. On a comparable basis, Dialysis Care revenue increased by 9%, partly compensated by negative growth in the acute services business following the termination of unprofitable contracts as well as the delay of certain de novo clinics. Care Coordination revenue decreased by 57% to EUR 300 million (-61% at constant currency), mainly driven by the prior-year revenue contribution from Sound as well as the implementation of IFRS 15. On a comparable basis, Care Coordination revenue decreased by 25% (-32% at constant currency). This decrease was mainly driven by the shift of calcimimetic drugs into the clinical environment as well as a higher prior-year revenue contribution due to the initial revenue recognition for the new 2017 ESCOs.

In the U.S., the average revenue per treatment, adjusted for the implementation of IFRS 15 and excluding the 2017 impact of the VA Agreement, increased by USD 15 from USD 341 to USD 356. The increase was mainly driven by the shift of calcimimetic drugs into the clinical environment, partially offset by lower revenue from commercial payors.

Cost per treatment in the U.S., adjusted for the implementation of IFRS 15 and prior-year natural disaster cost, increased by USD 19 from USD 271 to USD 290. This increase was largely a result of the introduction of calcimimetic drugs in the clinical environment, increased property and other occupancy related costs as well as the impact from one less dialysis day.

Dialysis Products revenue in North America increased by 2% to EUR 215 million (+1% at constant currency) due to higher sales of renal pharmaceuticals, peritoneal dialysis products, partially offset by lower sales of chronic hemodialysis products.

Total EBIT for the North America segment was EUR 525 million in the third quarter, an increase of 9% (+2% at constant currency). On a comparable basis, EBIT was EUR 538 million, an increase of 16%. The EBIT margin increased to 18.5% (18.9% on a comparable basis). The increase in EBIT margin on a comparable basis was mainly due to lower personnel expenses and the positive impact from income attributable to a consent agreement on certain pharmaceuticals.

In the first nine months of 2018, North America revenue decreased by 12% to EUR 8,589 million (-5% at constant currency). On comparable basis, revenue decreased by 5% (+1% at constant currency). Mainly driven by the gain related to divestitures of Care Coordination activities, EBIT went up by 47% (+57% at constant currency) to EUR 2,173 million in the first nine months of 2018.

As of the end of September 2018, the company was treating 201,220 patients (+3%) at its 2,486 clinics (+5%) in North America. Dialysis treatments increased by 3%.

EMEA revenue decreased by 2% (+1% at constant currency) to EUR 620 million in the third quarter of 2018, mainly driven by the positive development in Health Care Services revenue which increased by 4% at constant currency. The increase in Health Care Services revenue was driven by same-market treatment growth (+3%) and acquisitions, partially offset by the effect of sold and closed clinics as well as one less dialysis day. Health Care Products revenue decreased by 5% (-3% at constant currency) to EUR 306 million. Dialysis Products revenue decreased by 5% (-2% at constant currency), mainly due to lower sales of dialyzers, partially offset by higher sales of machines.

EBIT was EUR 88 million in the third quarter of 2018, a decrease of 18% (-16% at constant currency). The EBIT margin decreased from 16.8% to 14.1%, mainly due to the favorable prior-year impact from a legal settlement, higher personnel costs in certain countries, the impact of one less dialysis day and unfavorable foreign currency translation effects.

In the first nine months of 2018, EMEA revenue increased by 1% to EUR 1,908 million (+4% at constant currency), while EBIT of EUR 302 million was 10% below the prior year´s level (-9% at constant currency).

As of the end of September 2018, the company had 64,539 patients (+4%) being treated at 769 clinics (+5%) in the EMEA region. Dialysis treatments increased by 4%.

Asia-Pacific revenue grew by 3% to EUR 421 million (+4% at constant currency) in the third quarter of 2018. Dialysis Products showed again a solid business performance, with revenue growing 4% to EUR 227 million (+6% at constant currency). This growth was mainly driven by higher sales of hemodialysis products and products for acute care, particularly in China and Indonesia. Health Care Services revenue in the region increased by 1% to EUR 194 million (+1% at constant currency). Care Coordination revenue increased by 4% to EUR 54 million (+7% at constant currency). The growth in Care Coordination revenue in Asia Pacific was mainly related to a strong organic revenue growth and acquisitions. EBIT decreased by 14% to EUR 66 million (-14% at constant currency). The EBIT margin decreased to 15.7%, driven by unfavorable foreign currency transaction effects and increased costs for business growth.

In the first nine months of 2018, Asia-Pacific revenue increased by 2% to EUR 1,235 million (+8% at constant currency). EBIT decreased by 8% to EUR 218 million (-5% at constant currency).

As of the end of September 2018, the company had 31,152 patients (+3%) being treated at 390 clinics in Asia-Pacific (0%). Dialysis treatments increased by 2%.

Latin America delivered revenue of EUR 171 million in the third quarter of 2018, a decrease of 2%, but an increase of 27% at constant currency. The growth at constant currency was mainly due to a strong growth in Health Care Services (+34% at constant currency) driven by an increase in organic revenue per treatment mainly due to hyperinflation in Argentina, acquisitions and growth in same market treatments (+1%). Health Care Products revenue in Latin America decreased by 5% to EUR 49 million, but increased by 9% at constant currency. The increase in constant currency was due to higher sales of machines and products for acute care. EBIT in the third quarter was negative at EUR -1 million following the effects of hyperinflation in Argentina as well as unfavorable foreign currency transaction effects and higher bad debt expense. The EBIT margin was therefore also negative (-1%).

In the first nine months of 2018, Latin America revenue decreased by 6% to EUR 505 million, but increased by 18% at constant currency. EBIT was EUR 24 million, a decrease of 47% (-56% at constant currency).

As of the end of September 2018, the company was treating 32,174 patients (+5%) at 227 clinics in Latin America (-1%). Dialysis treatments increased by 4%.

Corporate cost in the third quarter were EUR 76 million on a comparable basis (flat at constant currency). Including the increased provision for the FCPA related charge in the amount of EUR 75 million, corporate cost amounted to EUR 151 million.

Net interest expense was EUR 74 million compared to EUR 86 million in the third quarter of 2017, a decrease of 14% (-14% at constant currency). The decrease was driven by a decreased debt level and interest income from the investment of the Sound proceeds. Income tax expense was EUR 104 million in the third quarter of 2018, which translates into an effective tax rate of 22.9%, compared to last year’s Q3 tax rate of 29.0%. The strong reduction was largely driven by the U.S. Tax Reform and the gain related to divestitures of Care Coordination activities, partly offset by non-tax-deductible expenses (mainly 2018 FCPA related charges and U.S. ballot initiatives).

Cash flow

In the third quarter of 2018, the company generated EUR 609 million of operating cash flow, compared to EUR 612 million in the previous year’s third quarter. This slight decrease was mainly driven by higher tax payments and discretionary contributions to pension plan assets in the U.S., almost fully offset by decreases in accounts receivable. Operating cash flow in percent of revenue was 15.0% in the third quarter of 2018. The number of days sales outstanding decreased sequentially by five days compared with Q2 2018 to reach 77 days. Free cash flow (Net cash used in operating activities, after capital expenditures, before acquisitions and investments) amounted to EUR 352 million for the three months ended September 30, 2018 compared to EUR 386 million for the same period of 2017. Free cash flow in percent of revenue was 8.7% and 8.9% for the three months ended September 2018 and 2017, respectively.

Outlook 2018

The company expects revenue3 growth between 2% and 3% at constant currency. Net income on a comparable basis4 is expected to increase by 11% to 12% at constant currency and on an adjusted basis4,5 to increase by 2% to 3% at constant currency.

The targets exclude the effect from the planned acquisition of NxStage Medical.

3 2017 adjusted for the effect of IFRS 15 implementation and the contribution of Sound Physicians in H2 2017
4 Attributable to shareholders of Fresenius Medical Care AG & Co. KGaA, adjusted for the contribution from Sound Physicians in H2 2017 and gain/loss related to divestitures of Care Coordination activities, 2018 FCPA related charge and U.S. Ballot Initiatives.
5 VA Agreement, Natural Disaster Costs, 2017 FCPA related charge, U.S. Tax Reform

Other updates

Regarding the planned acquisition of NxStage Medical, Inc. the parties have agreed to extend their closing deadline to February 5, 2019, but continue to expect closing within this year.

As of September 30, 2018, Fresenius Medical Care had 112,134 employees (full-time equivalents) worldwide, compared to 113,648 employees at the end of September 2017. This decrease was mainly attributable to the divestiture of Sound.

There will be a change to the composition of the Supervisory Board. Deborah Doyle McWhinney will resign effective November 1, 2018 due to private reasons. A replacement process has been initiated.

On October 30, 2018 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported that the Company’s fulvestrant formulation has not met the primary bioequivalence endpoints evaluating Eagle’s formulation compared to FASLODEX in its open label, randomized, pharmacokinetic (PK) and safety study conducted in 600 healthy female volunteers across multiple U.S. sites (Press release, Eagle Pharmaceuticals, OCT 30, 2018, View Source [SID1234530582]).

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The Company will continue to evaluate the data, but as a result of this outcome, Eagle intends to focus on advancing the development of other products in its pipeline.

Eagle’s fulvestrant product was intended to be administered at the recommended dose with one intramuscular injection instead of two high-viscosity intramuscular injections for FASLODEX, and in less time. In addition, our low-viscosity formulation does not contain castor oil, and was intended for administration with a 23-gauge needle, which is 25% thinner than the current needle required to administer FASLODEX.

"At this time, and given the results of the fulvestrant trial, we plan to focus on other promising programs in our pipeline, including exertional heat stroke, a potential nerve agent indication and intramuscular formulation for RYANODEX, and our pemetrexed and vasopressin assets," stated Scott Tarriff, Chief Executive Officer.

On October 30, 2018 Blueprint Medicines Corporation (NASDAQ: BPMC), a leader in discovering and developing targeted kinase medicines for patients with genomically defined diseases, reported financial results and provided a business update for the third quarter ended September 30, 2018 (Press release, Blueprint Medicines, OCT 30, 2018, View Source;q=View Source;source=gmail&ust=1541070221980000&usg=AFQjCNEV72tiQ5N9U9Dom5ERVILd_aDycQ [SID1234530361]).

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"Our third quarter and recent accomplishments represent tremendous progress across our portfolio, marked by the receipt of positive regulatory feedback from the FDA for avapritinib and BLU-667 and the presentation of new data across our clinical- and research-stage pipeline," said Jeff Albers, Chief Executive Officer of Blueprint Medicines. "As we prepare to enter a critical year, we are now accelerating our efforts with a focus on executing five registration-enabling studies across seven patient populations, building a global commercial enterprise to deliver medicines to patients and investing in the next generation of precision therapies."

Clinical Programs:

Avapritinib: Systemic Mastocytosis (SM)

Blueprint Medicines announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to avapritinib for the treatment of patients with advanced SM, including the subtypes of aggressive SM, SM with an associated hematologic neoplasm and mast cell leukemia.
Blueprint Medicines announced that it has screened the first patient in PATHFINDER, its registration-enabling, open-label, single-arm Phase 2 clinical trial in patients with advanced SM. Blueprint Medicines expects to initiate PIONEER, its registration-enabling, randomized, placebo-controlled Phase 2 clinical trial in patients with indolent and smoldering SM, by the end of 2018.
Blueprint Medicines announced that the European Medicines Agency has granted orphan drug designation to avapritinib for the treatment of mastocytosis.
Enrollment in the expansion portion of the Phase 1 EXPLORER clinical trial for advanced SM is ongoing. Blueprint Medicines plans to present data from this trial at the 60thAmerican Society for Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2018.
Avapritinib: Gastrointestinal Stromal Tumors (GIST)

Blueprint Medicines continues to evaluate avapritinib in its Phase 1 NAVIGATOR clinical trial and will present updated data across multiple patient populations, including PDGFRA-driven GIST, third-line or later GIST, and second-line GIST, at the 2018 Connective Tissue Oncology Society (CTOS) Annual Meeting on November 15, 2018. Based on data from this trial, Blueprint Medicines plans to submit a new drug application (NDA) to the FDA for avapritinib for the treatment of patients with PDGFRα Exon 18 mutant GIST and fourth-line GIST in the first half of 2019.
BLU-667: RET-Altered Solid Tumors

Blueprint Medicines recently received written feedback from the FDA supporting expedited development of BLU-667 and plans to submit an NDA for BLU-667 in the first half of 2020 based on additional data from the ongoing Phase 1 ARROW trial. Based on the feedback from the FDA, Blueprint Medicines currently expects the NDA submission will be for separate potential indications: (1) patients with RET-fusion positive NSCLC and papillary thyroid cancer (PTC) who have progressed following prior systemic therapy and (2) patients with RET-mutant medullary thyroid cancer (MTC) who have progressed following treatment with a tyrosine kinase inhibitor.
In October 2018, Blueprint Medicines presented updated data from its ongoing Phase 1 ARROW clinical trial of BLU-667 in patients with MTC and PTC at the 88th Annual Meeting of the American Thyroid Association. The data showed that BLU-667 is highly active and well-tolerated in these patient populations, with increased activity observed at higher dose levels and longer treatment durations. Ninety percent of evaluable patients with MTC and PTC experienced radiographic tumor reductions, regardless of RET alteration or prior multi-kinase inhibitor therapy. The response rate was 62 percent in patients with MTC in the 300 and 400 milligram once daily dose groups who were treated for at least 24 weeks. The data also showed that BLU-667 was well-tolerated, and most adverse events reported by investigators were Grade 1. Read the full data here.
In September 2018, Blueprint Medicines presented two clinical case studies demonstrating proof-of-concept for BLU-667 in combination with Tagrisso (osimertinib) in patients with treatment-resistant, EGFR-mutant NSCLC harboring an acquired RET fusion. The data showed that the combination of BLU-667 and osimertinib overcame resistance to standard therapy, and both patients achieved a partial response with a 78 percent reduction in target tumors per RECIST version 1.1. In these two patients, the combination was well-tolerated, and all reported adverse events were Grade 1 or 2. Read the full data here.
BLU-554: Hepatocellular Carcinoma (HCC)

In September 2018, Blueprint Medicines and its partner, CStone Pharmaceuticals, submitted an investigational new drug (IND) application for BLU-554 to Chinese health authorities. Subject to approval of the IND application, the companies plan to expand Blueprint Medicines’ ongoing Phase 1 clinical trial of BLU-554 as a monotherapy for the treatment of advanced HCC to include clinical sites in Mainland China. Additionally, the companies plan to initiate a proof-of-concept clinical trial evaluating BLU-554 in combination with CS1001, a clinical-stage anti-PD-L1 immunotherapy, in 2019.
Research Programs:

BLU-782: Fibrodysplasia Ossificans Progressiva (FOP)

In September 2018, Blueprint Medicines presented preclinical proof-of-concept data for BLU-782, an investigational precision therapy specifically designed to target the underlying cause of FOP, at the 2018 American Society for Bone and Mineral Research Annual Meeting. The data showed that BLU-782 prevented injury- and surgery-induced heterotrophic ossification, reduced edema and restored healthy tissue response to muscle injury in a well-characterized FOP mouse model. Read the full data here.
Blueprint Medicines expects to submit an IND application to the FDA for BLU-782 by the end of 2018, and subject to review of the IND application, plans to initiate a Phase 1 clinical trial in healthy volunteers in the first quarter of 2019. Upon completion of the Phase 1 clinical trial, Blueprint Medicines plans to advance BLU-782 into a registration-enabling Phase 2 clinical trial in patients with FOP.
Corporate:

In October 2018, Blueprint Medicines announced the expansion of its leadership team with the appointment of Christina Rossi as Chief Commercial Officer. Blueprint Medicines also announced the appointment of Paul Beresford as General Manager, International.
Third Quarter Financial Results:

Cash Position: As of September 30, 2018, cash, cash equivalents and investments were $559.6 million, as compared to $673.4 million as of December 31, 2017. This decrease was primarily related to cash used in operating activities, partially offset by the $40.0 million upfront payment received in connection with entering into the collaboration with CStone Pharmaceuticals and the $10.0 million milestone payment achieved under the Roche collaboration in June 2018.
Collaboration Revenues: Collaboration revenues were $1.1 million for the third quarter of 2018, as compared to $8.1 million for the third quarter of 2017. This decrease was primarily due to the termination of the Alexion agreement in 2017.
R&D Expenses: Research and development expenses were $64.6 million for the third quarter of 2018, as compared to $39.3 million for the third quarter of 2017. This increase was primarily attributable to increased clinical and manufacturing expenses associated with advancing avapritinib and BLU-667 further through clinical trials and increased personnel-related expenses. Research and development expenses included $4.8 million in stock-based compensation expenses for the third quarter of 2018.
G&A Expenses: General and administrative expenses were $12.0 million for the third quarter of 2018, as compared to $7.4 million for the third quarter of 2017. This increase was primarily due to increased personnel-related expenses and increased professional fees, including pre-commercial planning activities. General and administrative expenses included $3.6 million in stock-based compensation expenses for the third quarter of 2018.
Net Loss: Net loss was $72.7 million for the third quarter of 2018, or a net loss per share of $1.66, as compared to a net loss of $37.7 million for the third quarter of 2017, or a net loss per share of $0.96.
Financial Guidance:

Based on its current plans, Blueprint Medicines expects that its existing cash, cash equivalents and investments, excluding any potential option fees and milestone payments under its existing collaborations with Roche and CStone Pharmaceuticals, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the second half of 2020.

Earnings Conference Call Information:

Blueprint Medicines will host a live conference call and webcast at 8:30 a.m. ET today to discuss third quarter 2018 financial results and recent business activities. The conference call may be accessed by dialing (855) 626-8618 (domestic) or (531) 289-2784 (international) and referring to conference ID 7598866. A webcast of the conference call will be available in the Investors section of the Blueprint Medicines’ website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

CTOS Conference Call Information:

Blueprint Medicines will host a live conference call and webcast to discuss data being presented at the 2018 CTOS Annual Meeting on November 15th at 7:30 a.m. ET. The conference call may be accessed by dialing (855) 728-4793 (domestic) or (503) 343-6666 (international) and referring to conference ID 3479587. A webcast of the conference call will be available in the Investors section of the Blueprint Medicines’ website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

On October 30, 2018 Alligator Bioscience AB (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, reported that a new bispecific drug candidate, ATOR-1144, has entered preclinical development (Press release, Alligator Bioscience, OCT 30, 2018, View Source [SID1234538675]). ATOR-1144 is a first-in-class bispecific tumor-localized antibody targeting the checkpoint inhibitor CTLA-4 and the co-stimulatory receptor GITR.

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The bispecific antibody ATOR-1144 is a dual immune activator targeting CTLA-4 and GITR. It works through several pathways, including activation of T cells, depletion of regulatory T cells (Tregs) and activation of NK (natural killer) cells, for enhanced tumor cell killing. Based on its mode of action, ATOR-1144 may be suitable for the treatment of solid tumors as well as hematological cancers.

"We are very excited about the new drug candidate ATOR-1144, which is a novel tumor-localizing CTLA-4 bispecific antibody with the potential for enhanced Treg depletion. This latest progress further demonstrates Alligator’s capabilities in generating innovative bispecific immunotherapies", said Per Norlén, CEO of Alligator Bioscience.

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 286 44 95
E-mail: [email protected]

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 2:00 p.m. CET on October 30, 2018.

About ATOR-1144
ATOR-1144 is a bispecific antibody drug candidate targeting both CTLA-4 and GITR. It is a combination of a GITR specific antibody isolated from ALLIGATOR-GOLD, while the CTLA-4 part was developed by FINDoptimization of CD86, a natural CTLA-4 ligand. GITR (Glucocorticoid-Induced TNFR family Related) is a member of the TNFR superfamily (TNFRSF) that is expressed in different cell types, including T lymphocytes and NK cells.