On October 29, 2019 Bio-Techne Corporation (NASDAQ:TECH) reported its financial results for the first quarter ended September 30, 2019 (Press release, Bio-Techne, OCT 29, 2019, View Source [SID1234549985]).

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First Quarter FY2020 Snapshot

First quarter organic revenue increased by 13% (12% reported) to $183.2 million.
GAAP EPS was $0.37 versus $0.45 one year ago. Delivered adjusted earnings per share (EPS) of $1.06, an increase of 8% over the prior year.
Both segments delivered solid double-digit organic growth with Diagnostics and Genomics at 16% and Protein Sciences at 12%.
Construction commenced on a state-of-the-art GMP manufacturing facility to support our expanding cell and gene therapy portfolio.
More than 60 million Medicare beneficiaries will be covered for the ExoDx Prostate IntelliScore (EPI) test on December 1, 2019, upon finalization of the Local Coverage Decision from the Medicare Administrative Contractor.
The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States (GAAP). Adjusted EPS, adjusted earnings, adjusted gross margin, adjusted operating income, and adjusted operating margin are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of non-GAAP Adjusted Financial Measures." A reconciliation of GAAP to non-GAAP financial measures is included in this press release.

"We opened fiscal 2020 posting an outstanding first quarter," said Chuck Kummeth, President and Chief Executive Officer of Bio-Techne. "The 13% organic growth for the quarter was the result of very good execution from our global team and our strong product portfolio, which remains extremely vital in research workflow for our customers."

Kummeth added, "Our end-markets, including BioPharma and Europe, remain healthy, while China continues to outperform at nearly 20% growth. I’m very proud of the team for this excellent start to the year and very optimistic about our future execution and growth due to all the exciting new products and services we offer as a valued partner to researchers worldwide. "

First Quarter Fiscal 2020

Revenue

Net sales for the first quarter increased 12% to $183.2 million. Organic growth was 13% compared to the prior year, with foreign currency exchange having an unfavorable impact of 1% and acquisitions contributing less than 1% to revenue growth.

GAAP Earnings Results

GAAP EPS decreased to $0.37 per diluted share, versus $0.45 in the same quarter last year. GAAP EPS was unfavorably impacted by an unrealized loss on our ChemoCentryx investment. GAAP operating income for the first quarter of fiscal 2020 increased 29.4% to $33.3 million, compared to $25.8 million in the first quarter of fiscal 2019. GAAP operating margin was 18.2%, compared to 15.8% in the first quarter of fiscal 2019. GAAP operating margin compared to prior year was positively impacted by the timing of stock compensation expense recognized as a result of adding new requirements for certain vesting eligibility.

Non-GAAP Earnings Results

Adjusted EPS increased to $1.06 per diluted share, versus $0.98 in the same quarter last year, an increase of 8% resulting from higher sales volumes. Adjusted operating income for the first quarter of fiscal 2020 increased 6% compared to the first quarter of fiscal 2019. Adjusted operating margin was 31.8%, compared to 33.9% in the first quarter of fiscal 2019. Adjusted operating margin compared to the prior year was negatively impacted by recent acquisitions and unfavorable foreign exchange rates.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the Company’s business segments, as highlighted below. Since these results are used for this purpose, they are also considered to be prepared in accordance with GAAP.

Protein Sciences Segment

The Company’s Protein Sciences segment is one of the world’s leading suppliers of specialized proteins such as cytokines and growth factors, immunoassays, antibodies and reagents, to the biotechnology community. Additionally, the segment provides an array of platforms useful in various areas of protein analysis. Protein Sciences segment’s first quarter fiscal 2020 net sales were $141.0 million, an increase of 12% from $126.4 million for the first quarter of fiscal 2019. Organic growth for the segment was 12%, with foreign currency exchange having an unfavorable impact of 1% on revenue growth and acquisitions contributing 1% to revenue growth. Protein Sciences segment’s operating margin was 42.2% in the first quarter of fiscal 2020 compared to 43.2% in the first quarter of fiscal 2019. The segment’s operating margin compared to the prior year was negatively impacted by product mix and unfavorable foreign exchange.

Diagnostics and Genomics Segment

The Company’s Diagnostics and Genomics segment provides blood chemistry and blood gas quality controls, hematology instrument controls, diagnostics immunoassays and other bulk and custom reagents for the in vitro diagnostic market. The Diagnostics and Genomics segment also develops and provides in situ hybridization products as well as exosome-based diagnostics for various pathologies, including prostate cancer. The Diagnostics and Genomics segment’s first quarter fiscal 2020 net sales were $42.6 million compared to $36.7 million for the first quarter of fiscal 2019. Organic growth for the segment was 16%, with foreign currency exchange having an unfavorable impact of 1% and acquisitions contributing 1%. The Diagnostics and Genomics segment’s operating margin was 2.1% in the first quarter of fiscal 2020 compared to 6.9% in the first quarter of fiscal 2019. The segment’s operating margin was negatively impacted by the acquisition of Exosome which was acquired in August of 2019.

Conference Call

Bio-Techne will host an earnings conference call today, October 29, 2019 at 8:00 a.m. CDT. To listen, please dial 1-888-394-8218 or 1-323-701-0225 for international callers, and reference conference ID 5097333. A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by going to:

View Source

The replay will be available from 11:00 a.m. CDT on Tuesday, October 29, 2019 until 11:00 p.m. CST on Friday, November 29, 2019.

Use of non-GAAP Adjusted Financial Measures:

This press release contains financial measures that have not been calculated in accordance with accounting principles generally accepted in the U.S. (GAAP). These non-GAAP measures include:

Organic growth
Adjusted diluted earnings per share
Adjusted net earnings
Adjusted gross margin
Adjusted operating income
Adjusted operating margin
We provide these measures as additional information regarding our operating results. We use these non-GAAP measures internally to evaluate our performance and in making financial and operational decisions, including with respect to incentive compensation. We believe that our presentation of these measures provides investors with greater transparency with respect to our results of operations and that these measures are useful for period-to-period comparison of results.

Our non-GAAP financial measure of organic growth represents revenue growth excluding revenue from acquisitions within the preceding 12 months as well as the impact of foreign currency. Excluding these measures provides more useful period-to-period comparison of revenue results as it excludes the impact of foreign currency exchange rates, which can vary significantly from period to period, and revenue from acquisitions that would not be included in the comparable prior period.

Our non-GAAP financial measures for adjusted gross margin, adjusted operating margin, and adjusted net earnings, in total and on a per share basis, exclude the costs recognized upon the sale of acquired inventory, amortization of acquisition intangibles, and acquisition related expenses. The Company excludes amortization of purchased intangible assets and purchase accounting adjustments, including costs recognized upon the sale of acquired inventory and acquisition-related expenses, from this measure because they occur as a result of specific events, and are not reflective of our internal investments, the costs of developing, producing, supporting and selling our products, and the other ongoing costs to support our operating structure. Additionally, these amounts can vary significantly from period to period based on current activity.

The Company’s non-GAAP adjusted operating margin and adjusted net earnings, in total and on a per share basis, also excludes stock-based compensation expense, which is inclusive of the employer portion of payroll taxes on those stock awards, restructuring, impairments of equity method investments, gain and losses from investments, and certain adjustments to income tax expense. Stock-based compensation is excluded from non-GAAP adjusted net earnings because of the nature of this charge, specifically the varying available valuation methodologies, subjective assumptions, variety of award types, and unpredictability of amount and timing of employer related tax obligations. Impairments of equity investments are excluded as they are not part of our day-to-day operating decisions. Additionally, gains and losses from other investments that are either isolated or cannot be expected to occur again with any predictability are excluded. Costs related to restructuring activities, including reducing overhead and consolidating facilities, are excluded because we believe they are not indicative of our normal operating costs. The Company independently calculates a non-GAAP adjusted tax rate to be applied to the identified non-GAAP adjustments considering the impact of discrete items on these adjustments and the jurisdictional mix of the adjustments. In addition, the tax impact of other discrete and non-recurring charges which impact our reported GAAP tax rate are adjusted from net earnings. We believe these tax items can significantly affect the period-over-period assessment of operating results and not necessarily reflect costs and/or income associated with historical trends and future results.

On October 29, 2019 Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small molecule oncology therapeutics, reported that it has dosed the first patient in its phase 1/2 clinical trial of LNS8801 in patients with advanced solid and hematologic cancers (Press release, Linnaeus Therapeutics, OCT 29, 2019, View Source [SID1234550001]). This marks the first time any company has dosed a patient in a clinical trial specifically targeting the G protein-coupled estrogen receptor (GPER). The initiation of the study follows U.S. Food and Drug Administration (FDA) clearance of the company’s investigational new drug application (IND) for LNS8801 in late September.

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LNS8801 is an orally bioavailable small molecule that is a highly specific and potent agonist of the GPER.

"We are thrilled to begin testing LNS8801 in patients with advanced cancer. We will have six outstanding academic comprehensive cancer centers all enthusiastically recruiting patients for this promising study," commented Patrick Mooney, MD, chief executive officer of Linnaeus. "LNS8801 has very real potential to provide meaningful and lasting clinical benefit for patients with cancer, and we look forward to providing updates over the course of the study."

The study entitled, "A Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of LNS8801 in Patients with Advanced Cancer," is designed in two parts. The phase 1 dose-escalation portion of the trial will assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of LNS8801. After a recommended phase 2 dose is established, dose expansion cohorts are anticipated.

About LNS8801
LNS8801 is an orally bioavailable and highly specific agonist of GPER whose activity is dependent on the expression of GPER. GPER activation suppresses well-known tumor-associated genes, such as c-Myc and PD-L1. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory. LNS8801 monotherapy has shown significant antitumor activity, including inducing complete responses that are immune to rechallenge. LNS8801 also has shown effects when combined with targeted therapies and immunotherapies. Preclinical toxicology studies have established a wide safety margin.

On October 29, 2019 Incyte Corporation (Nasdaq:INCY) reported 2019 third quarter financial results and provides a status update on the Company’s development portfolio (Press release, Incyte, OCT 29, 2019, View Source [SID1234549952]).

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"Revenue growth continues to be very strong, driven by robust demand for Jakafi (ruxolitinib) in all three approved indications and, as a result, we are raising guidance for full year Jakafi net sales," stated Hervé Hoppenot, Chief Executive Officer, Incyte. "At the beginning of 2019, we laid out an ambitious set of development goals for our late-stage portfolio, and in the third quarter we have continued to execute against them. The recent clinical success in the REACH2 trial of ruxolitinib in steroid-refractory acute GVHD; the updated data from pemigatinib in cholangiocarcinoma and subsequent NDA submission; and the recently-presented 52-week data from the randomized Phase 2 trial of ruxolitinib cream in vitiligo are all illustrative of the significant progress we have made this year."

Portfolio Update

Oncology – key highlights

The positive result of REACH2, the Phase 3 study evaluating ruxolitinib in patients with steroid-refractory acute graft-versus-host disease (GVHD), was announced in October. The study met its primary endpoint of superior overall response rate (ORR) at Day 28 with ruxolitinib treatment compared to best available therapy. No new safety signals were observed, and the ruxolitinib safety profile in REACH2 was consistent with that seen in previously reported studies in steroid-refractory acute GVHD.

A recent interim efficacy and safety analysis conducted by an Independent Data Monitoring Committee (IDMC) recommended that the Phase 3 REACH3 trial of ruxolitinib in patients with steroid-refractory chronic GVHD should continue without modification. The result of REACH3 is expected in 2020.

The top-line result from GRAVITAS-301, the Phase 3 trial of itacitinib as a treatment for patients with newly diagnosed acute GVHD, is expected to be available at the end of 2019. GRAVITAS-309, a Phase 3 trial of itacitinib as a treatment for patients with newly diagnosed chronic GVHD, was initiated in January of this year with results expected in 2021.

The NDA seeking approval for pemigatinib as a second-line treatment for cholangiocarcinoma patients with FGFR2 fusions or rearrangements was submitted to the U.S. Food and Drug Administration (FDA) under Breakthrough Therapy designation. Data from FIGHT-202, which supported the NDA, were presented at the recent European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

Enrollment in the continuous dosing cohort of FIGHT-201, the Phase 2 trial of pemigatinib in patients with bladder cancer, is expected to complete by the end of 2019 and FIGHT-207, a Phase 2 solid tumor-agnostic trial evaluating pemigatinib in patients with driver-activations of FGF/FGFR, has been initiated.

Indication and status
Ruxolitinib (JAK1/JAK2)
Steroid-refractory acute GVHD: Phase 3 (REACH2) met primary endpoint1

Steroid-refractory chronic GVHD: Phase 3 (REACH3)1

Essential thrombocythemia: Phase 2 (RESET)

Refractory myelofibrosis: Phase 2 with PI3Kδ, PIM or JAK1 inhibition

Itacitinib (JAK1)
Treatment-naïve acute GVHD: Phase 3 (GRAVITAS-301)

Treatment-naïve chronic GVHD: Phase 3 (GRAVITAS-309)

Pemigatinib (FGFR1/2/3)
Cholangiocarcinoma: Phase 2 (FIGHT-202), Phase 3 (FIGHT-302)

Bladder cancer: Phase 2 (FIGHT-201)

8p11 MPN: Phase 2 (FIGHT-203)

Tumor agnostic: Phase 2 (FIGHT-207)

Parsaclisib (PI3Kδ)
Follicular lymphoma: Phase 2 (CITADEL-203)

Marginal zone lymphoma: Phase 2 (CITADEL-204)

Mantle cell lymphoma: Phase 2 (CITADEL-205)

INCMGA0012 (PD-1)1
MSI-high endometrial cancer: Phase 2 (POD1UM-101)

Merkel cell carcinoma: Phase 2 (POD1UM-201)

Anal cancer: Phase 2 (POD1UM-202)

Notes:

(1)Clinical development of ruxolitinib in GVHD, including REACH2 and REACH3, conducted in collaboration with Novartis
(2)INCMGA0012 licensed from MacroGenics

Inflammation and autoimmunity (IAI) – key highlights

Evidence of continued improvement with longer-term treatment was shown in the 52-week data from the randomized Phase 2 trial of ruxolitinib cream in patients with vitiligo, which were recently presented at the European Academy of Dermatology and Venereology (EADV) Congress. The Phase 3 TRuE-V development program of ruxolitinib cream in patients with vitiligo was initiated in September, with initial results expected in 2021.

The Phase 3 TRuE-AD development program of ruxolitinib cream in patients with atopic dermatitis is ongoing, with initial results expected in the first half of 2020.

Indication and status
Ruxolitinib cream (JAK1/JAK2)
Atopic dermatitis: Phase 3 (TRuE-AD)

Vitiligo: Phase 3 (TRuE-V)

INCB54707 (JAK1)

Hidradenitis suppurativa: Phase 2
Itacitinib (JAK1) Ulcerative colitis: Phase 2
Parsaclisib (PI3Kδ)
Autoimmune hemolytic anemia: Phase 2

Sjögren’s syndrome: Phase 2

discovery and early development – key highlights

Incyte’s portfolio of earlier-stage clinical candidates is detailed below.

Modality Candidates
Small molecules
INCB01158 (ARG)1, INCB81776 (AXL/MER), INCB62079 (FGFR4), epacadostat (IDO1), INCB59872 (LSD1), INCB53914 (PIM), INCB86550 (PD-L1)

Monoclonal antibodies2 INCAGN1876 (GITR), INCAGN2385 (LAG-3), INCAGN1949 (OX40), INCAGN2390 (TIM-3)
Bispecific antibodies MCLA-145 (PD-L1xCD137)3

Notes:

(1) INCB01158 development in collaboration with Calithera
(2) Discovery collaboration with Agenus
(3) MCLA-145 development in collaboration with Merus

Partnered – key highlights

The status of Incyte’s partnered compounds is detailed below.

Indication and status
Baricitinib (JAK1/JAK2)1
Atopic dermatitis: Phase 3 (BREEZE-AD)

Systemic lupus erythematosus: Phase 3

Severe alopecia areata: Phase 3

Capmatinib (MET)2 NSCLC (with MET exon 14 skipping mutations): NDA expected in Q4 2019 (by Novartis)

Notes:

(1)Worldwide rights to baricitinib licensed to Lilly: approved as Olumiant in multiple territories globally for certain patients with moderate to severe rheumatoid arthritis
(2)Worldwide rights to capmatinib licensed to Novartis

2019 Third-Quarter and Year-to-Date Financial Results

The financial measures presented in this press release for the three and nine months ended September 30, 2019 and 2018 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 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.

Beginning in the first quarter of 2019, after reviewing our Reconciliation of GAAP Net Income to Selected Non-GAAP Adjusted Information with the U.S. Securities & Exchange Commission, we no longer adjust for upfront consideration and milestones that are part of collaboration agreements with new or existing partners. This revised methodology is reflected in this press release for the three and nine months ended September 30, 2019 and 2018.

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.

The Company’s 2019 financial guidance related to research and development and selling, general and administrative expenses does not include estimates associated with any potential future strategic transactions.

or the quarter ended September 30, 2019, net product revenues of Jakafi were $433 million as compared to $348 million for the same period in 2018, representing 25 percent growth. For the nine months ended September 30, 2019, net product revenues of Jakafi were $1.2 billion as compared to $1.0 billion for the same period in 2018, representing 21 percent growth. For the quarter ended September 30, 2019, net product revenues of Iclusig (ponatinib) were $21 million as compared to $20 million for the same period in 2018. For the nine months ended September 30, 2019, net product revenues of Iclusig were $66 million as compared to $61 million for the same period in 2018.

For the quarter and nine months ended September 30, 2019, product royalties from sales of Jakavi (ruxolitinib), which has been out-licensed to Novartis outside of the United States, were $58 million and $161 million, respectively, as compared to $51 million and $139 million, respectively, for the same periods in 2018. For the quarter and nine months ended September 30, 2019, product royalties from sales of Olumiant (baricitinib), which has been out-licensed to Lilly globally, were $22 million and $57 million, respectively, as compared to $11 million and $26 million, respectively, for the same periods in 2018.

For the quarter and nine months ended September 30, 2019, milestone and contract revenues earned from our collaborative partners were $18 million and $78 million, respectively, as compared to $20 million and $120 million, respectively, for the same periods in 2018.

Cost of product revenues GAAP cost of product revenues for the quarter and nine months ended September 30, 2019 was $30 million and $82 million, respectively, as compared to $25 million and $68 million, respectively, for the same periods in 2018. Non-GAAP cost of product revenues for the quarter and nine months ended September 30, 2019 was $24 million and $65 million, respectively, as compared to $19 million and $52 million, respectively, for the same periods in 2018. 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. and the cost of stock-based compensation.

Research and development expenses GAAP research and development expenses for the quarter and nine months ended September 30, 2019 were $281 million and $841 million, respectively, as compared to $293 million and $894 million, respectively, for the same periods in 2018. The decrease in GAAP research and development expenses over the prior year quarter and prior year nine month period was driven primarily by our decision to no longer co-fund the development of baricitinib with Lilly and lower costs related to the epacadostat program, partially offset by costs to advance our other internal development programs.

Non-GAAP research and development expenses for the quarter and nine months ended September 30, 2019 were $251 million and $756 million, respectively, including upfront and milestone expenses related to collaborative agreements of $0 million and $25 million, respectively. Non-GAAP research and development expenses for the quarter and nine months ended September 30, 2018 were $266 million and $818 million, respectively, including upfront and milestone expenses related to collaborative agreements of $15 million and $47 million, respectively. Non-GAAP research and development expenses exclude the cost of stock-based compensation.

Selling, general and administrative expenses GAAP selling, general and administrative expenses for the quarter and nine months ended September 30, 2019 were $103 million and $333 million, respectively, as compared to $97 million and $326 million, respectively, for the same periods in 2018.

Non-GAAP selling, general and administrative expenses for the quarter and nine months ended September 30, 2019 were $90 million and $294 million, respectively, as compared to $85 million and $291 million, respectively, for the same periods in 2018. 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, 2019 and was $3 million and $17 million, respectively, as compared to $5 million and $19 million, respectively, for the same periods in 2018.

Unrealized gain (loss) on long term investments GAAP unrealized gain on long term investments for the quarter and nine months ended September 30, 2019 was $2 million and $19 million, respectively. GAAP unrealized loss on long term investments for the quarter and nine months ended September 30, 2018 was $10 million and $22 million, respectively. The unrealized gain (loss) on long term investments represents the fair market value adjustments of the Company’s investments in Agenus, Calithera, Merus and Syros.

Net income GAAP net income for the quarter ended September 30, 2019 was $128 million, or $0.60 per basic and $0.59 per diluted share, as compared to net income of $29 million, or $0.14 per basic and diluted share for the same period in 2018. GAAP net income for the nine months ended September 30, 2019 was $336 million, or $1.57 per basic and $1.55 per diluted share, as compared to net income of $40 million, or $0.19 per basic and diluted share for the same period in 2018.

Non-GAAP net income for the quarter ended September 30, 2019 was $179 million, or $0.83 per basic and $0.82 per diluted share, as compared to Non-GAAP net income of $87 million, or $0.41 per basic and diluted share for the same period in 2018. Non-GAAP net income for the nine months ended September 30, 2019 was $476 million, or $2.22 per basic and $2.19 per diluted share, as compared to Non-GAAP net income of $208 million, or $0.98 per basic and $0.97 per diluted share for the same period in 2018.

(1)Adjusted to exclude the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the estimated cost of stock-based compensation.
(2)Adjusted to exclude the estimated cost of stock-based compensation.
(3)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 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 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, 13695247.

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, 13695247.

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 29, 2019 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $218.8 million and screened approximately 456,000 people with Cologuard during the quarter ended September 30, 2019. Third-quarter 2019 revenue and test volume grew 85 percent and 89 percent, respectively, from the same period of 2018 (Press release, Exact Sciences, OCT 29, 2019, View Source [SID1234549970]).

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"The Exact Sciences team delivered another strong quarter and most importantly, has screened more than 3 million people with Cologuard over the last 5 years," said Kevin Conroy, chairman and CEO of Exact Sciences. "The team made significant progress enhancing our internal infrastructure with the opening of our new lab and implementation of Epic’s best-in-class electronic health record system. The foundation we’ve built for Cologuard and our planned combination with Genomic Health position Exact Sciences to be the cancer diagnostics leader for years to come."

Third-Quarter 2019 Financial Results

For the three-month period ended September 30, 2019, as compared to the same period of 2018 (where applicable):

Revenue was $218.8 million, an increase of 85 percent, and Cologuard test volume was 456,000, an increase of 89 percent
Average Cologuard recognized revenue per test was $479, a decline of $13
Average Cologuard cost per test was $114, an improvement of $10 per test
Gross margin was 76 percent, an increase of 130 basis points
Operating expenses were $201.7 million, an increase of 56 percent
Transaction-related costs for the planned Genomic Health combination were $7.1 million, and integration-related costs were $2.1 million
Net loss was $40.5 million, or $0.31 per share, compared to $45.4 million, or $0.37 per share
Non-cash interest expense related to convertible debt was $11.0 million, or $0.08 per share, compared to $8.4 million, or $0.07 per share
Cash utilization was $78.9 million, compared to $36.9 million; the third quarter cash use included $43.2 million of fees paid to Pfizer for services incurred from October 2018 through the end of June 2019
Cash, cash equivalents and marketable securities were $1.2 billion at the end of the quarter
2019 Outlook

The company anticipates revenue of $802-$810 million during 2019. The company’s revenue guidance does not include the impact of the pending combination with Genomic Health.
The company’s guidance for revenue is a forward-looking statement. It is subject to various risks and uncertainties that could cause the company’s actual results to differ materially from the anticipated targets. There can be no assurance the company will meet these financial projections. See the cautionary information about forward-looking statements in the "Forward-Looking Statements" section of this news release.

Third-Quarter Conference Call & Webcast

Company management will host a conference call and webcast on Tuesday, October 29, 2019, at 5 p.m. ET to discuss third-quarter 2019 results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 833-235-7650 and international callers should dial +1-647-689-4171.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 4168628. The webcast, conference call and replay are open to all interested parties.

About Cologuard
Cologuard was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use Cologuard if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. Cologuard is not a replacement for colonoscopy in high risk patients. Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. Cologuard performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. False positives and false negative results can occur. In a clinical study, 13% of people without cancer or precancer received a positive result (false positive) and 8% of people with cancer received a negative result (false negative).

Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.

On October 29, 2019 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported that it will deliver a proffered paper (oral) presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress 2019, which is being held December 11-14 at the Palexpo in Geneva, Switzerland (Press release, BioLineRx, OCT 29, 2019, View Source [SID1234549986]).

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Presentation details:

Abstract title: A Multi-Center Phase 2a Trial to Assess the Safety and Efficacy of BL-8040 (a CXCR4 inhibitor) in Combination with Pembrolizumab and Chemotherapy in Patients with Metastatic Pancreatic Adenocarcinoma (PDAC)

Date: Friday, December 13, 2019

Presentation No.: 91O

Lecture time: 11:15-11:30am CET

Location: Room C

About BL-8040

BL-8040 is a short synthetic peptide that functions as a high-affinity best-in-class antagonist for CXCR4, a chemokine receptor over-expressed in many human cancers, where it has been shown to be correlated with poor prognosis, and plays a key role in tumor growth, invasion, angiogenesis, metastasis and therapeutic resistance. CXCR4 is also directly involved in the homing and retention of hematopoietic stem cells (HSCs) and various hematological malignant cells in the bone marrow.

In a number of clinical and pre-clinical studies, BL-8040 has shown a critical role in immune cell trafficking, tumor infiltration by immune effector T cells and reduction in immunosuppressive cells within the tumor niche, turning "cold" tumors, such as pancreatic cancer, into "hot" tumors (i.e., sensitizing them to immune check point inhibitors). BL-8040-mediated inhibition of the CXCR4-CXCL12 (SDF-1) axis has also shown robust mobilization of HSCs for transplantation in hematological malignancies.

BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.