1stOncology™: Cancer Intelligence Service – Page 14483 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

LEXICON PHARMACEUTICALS REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS AND PROVIDES A BUSINESS UPDATE

On July 30, 2018 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results and provided a business update for the three months ended June 30, 2018 (Press release, Lexicon Pharmaceuticals, JUL 30, 2018, View Source;2018.htm [SID1234527964]).

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!

"We continue to make progress across our portfolio while maintaining good financial discipline," said Lonnel Coats, Lexicon’s president and chief executive officer. "In the second quarter, we experienced significant momentum around our sotagliflozin program with the FDA’s acceptance of our collaborator Sanofi’s NDA filing for type 1 diabetes and the recent publications of the pivotal sotagliflozin studies in Diabetes Care. In addition, Sanofi is making excellent progress in enrolling the Phase 3 studies in the type 2 diabetes program. In the second half of the year, we anticipate continued advancement of our pipeline, which we believe will create long-term value for the company."

Second Quarter Product and Pipeline Highlights

XERMELO (telotristat ethyl) 250 mg

Favorable data on body weight from the randomized, double-blind, placebo-controlled Phase 3 TELESTAR (Telostristat Etiprate for Somatostatin Analog Not Adequately Controlled Carcinoid Syndrome) study were published in Clinical Therapeutics in May.

Sotagliflozin

In May, the U.S. Food and Drug Administration (FDA) accepted Lexicon collaborator Sanofi’s New Drug Application (NDA) for sotagliflozin for use in combination with insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus with a PDUFA date of March 22, 2019.

Positive 52-week inTandem1 and inTandem2 data were presented at the 78th Scientific Sessions of the American Diabetes Association (ADA) and published in Diabetes Care in June.

Second Quarter 2018 Financial Highlights

Revenues: Revenues for the three months ended June 30, 2018 increased to $13.8 million from $12.1 million for the corresponding period in 2017, primarily due to an increase in net product revenues, partially offset by lower revenues recognized from the collaboration and license agreement with Sanofi. Net product revenues for the three months ended June 30, 2018 included $6.0 million from net sales of XERMELO in the U.S., up 65% from the prior year quarter and 11% from the first quarter of 2018, and $1.3 million from the sale of bulk tablets of XERMELO to Ipsen.

Cost of Sales: Cost of sales related to sales of XERMELO for the three months ended June 30, 2018 increased to $0.8 million from $0.5 million for the corresponding period in 2017.

Research and Development (R&D) Expenses: Research and development expenses for the three months ended June 30, 2018 were $26.6 million compared to $26.9 million for the corresponding period in 2017.

Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for three months ended June 30, 2018 decreased to $16.8 million from $18.5 million for the corresponding period in 2017, primarily due to decreased marketing costs.

Net Loss: Net loss for the three months ended June 30, 2018 was $34.7 million, or $0.33 per share, compared to a net loss of $35.1 million, or $0.33 per share, in the corresponding period in 2017. For the three months ended June 30, 2018 and 2017, net loss included non-cash, stock-based compensation expense of $2.9 million and $2.4 million, respectively.

Cash and Investments: As of June 30, 2018, Lexicon had $209.7 million in cash and investments, as compared to $310.8 million as of December 31, 2017.

Anticipated Upcoming Milestones in 2H 2018

Sotagliflozin data presentations at the 54th Annual Meeting of the European Association for the Study of Diabetes (EASD; October 1-5, 2018; Berlin, Germany)

Phase 1b data for LX2761 in type 2 diabetes

Initiation of clinical development of telotristat ethyl in oncology

Phase 1a data for LX9211 (neuropathic pain candidate) in healthy volunteers

Manuscript publications for XERMELO and sotagliflozin

Launch of XERMELO by Ipsen in additional European countries

Conference Call and Webcast Information

Lexicon management will hold a live conference call and webcast today at 8:00 am EDT / 7:00 am CDT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is 888-645-5785 (U.S./Canada) or 970-300-1531 (international). The conference ID for all callers is 8776903. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/investors. An archived version of the webcast will be available on the website for 14 days.

About XERMELO (telotristat ethyl)

Discovered using Lexicon’s unique approach to gene science, XERMELO (telostristat ethyl) is the first and only approved oral therapy for carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSAs. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. Lexicon has built the in-house capability and infrastructure to launch and market XERMELO in the U.S., where it retains all commercialization rights. Lexicon also retains rights to market XERMELO in Japan. Lexicon has established a license and collaboration agreement with Ipsen to commercialize XERMELO in Europe and other countries outside of U.S. and Japan.

XERMELO was approved by the U.S. Food and Drug Administration on February 28, 2017 and by the European Commission on September 19, 2017 for the treatment of carcinoid syndrome diarrhea in combination with SSA therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with metastatic NETs (mNETs) and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

XERMELO (telotristat ethyl) Important Safety Information

Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.

Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.

Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.

For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

About Sotagliflozin

Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an investigational oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney.

Lexicon entered into a collaboration and license agreement with Sanofi in November 2015 under which Lexicon granted Sanofi an exclusive, worldwide (excluding Japan), royalty-bearing right and license to develop, manufacture and commercialize sotagliflozin. Lexicon is responsible for all clinical development activities relating to type 1 diabetes and has exercised an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialization of sotagliflozin for the treatment of type 1 diabetes in the U.S. Sanofi is responsible for all clinical development and commercialization of sotagliflozin for the treatment of type 2 diabetes worldwide (excluding Japan) and is solely responsible for the commercialization of sotagliflozin for the treatment of type 1 diabetes outside the U.S. (excluding Japan).

Kura Oncology to Report Second Quarter 2018 Financial Results

On July 30, 2018 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported that it will report second quarter 2018 financial results after the close of U.S. financial markets on Monday, August 6, 2018 (Press release, Kura Oncology, JUL 30, 2018, View Source [SID1234527963]). Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT that day to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing 877-516-3514 for domestic callers and 281-973-6129 for international callers and entering the conference code: 1588245. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.kuraoncology.com.

Illumina Reports Financial Results for Second Quarter of Fiscal Year 2018

On July 30, 2018 Illumina, Inc. (NASDAQ:ILMN) reported its financial results for the second quarter of fiscal year 2018 (Press release, Illumina, JUL 30, 2018, View Source [SID1234527962]).

Second quarter 2018 results:

Revenue of $830 million, a 25% increase compared to $662 million in the second quarter of 2017

GAAP net income attributable to Illumina stockholders for the quarter of $209 million, or $1.41 per diluted share, compared to $128 million, or $0.87 per diluted share, for the second quarter of 2017

Non-GAAP net income attributable to Illumina stockholders for the quarter of $212 million, or $1.43 per diluted share, compared to $121 million, or $0.82 per diluted share, for the second quarter of 2017 (see the table entitled "Itemized Reconciliation Between GAAP and Non-GAAP Net Income Attributable to Illumina Stockholders" for a reconciliation of these GAAP and non-GAAP financial measures)

Cash flow from operations of $295 million compared to $178 million in the second quarter of 2017

Free cash flow (cash flow from operations less capital expenditures) of $218 million for the quarter, compared to $109 million in the second quarter of 2017

Gross margin in the second quarter of 2018 was 69.3% compared to 65.5% in the prior year period. Excluding amortization of acquired intangible assets, non-GAAP gross margin was 70.3% for the second quarter of 2018 compared to 67.0% in the prior year period.

Research and development (R&D) expenses for the second quarter of 2018 were $151 million compared to $130 million in the prior year period. Non-GAAP R&D expenses as a percentage of revenue were 18.2%, including 0.9% attributable to Helix. This compares to non-GAAP R&D expenses as a percentage of revenue of 19.7% in the prior year period, including 0.8% attributable to Helix.

Selling, general and administrative (SG&A) expenses for the second quarter of 2018 were $197 million compared to $161 million in the prior year period. Non-GAAP SG&A expenses as a percentage of revenue were 23.7%, including 1.0% attributable to Helix. This compares to 25.2% in the prior year period, including 1.0% attributable to Helix.

Depreciation and amortization expenses were $44 million and capital expenditures for free cash flow purposes were $77 million during the second quarter of 2018. At the close of the quarter, the company held $2.5 billion in cash, cash equivalents and short-term investments, compared to $2.1 billion as of December 31, 2017.

"Driven by broad demand across applications, systems and geographies, revenue grew 25% from the second quarter of 2017, and we are now expecting revenue growth of approximately 20% for 2018," said Francis deSouza, President and CEO. "Sequencing consumables, array consumables, and lab and other services each grew more than 30% compared to the second quarter of 2017, highlighting the growing interest in genomic information and its application to research, clinical and consumer markets."

Updates since our last earnings release:

Launched the S4 200 cycle kit (available in the fourth quarter of 2018) on NovaSeq which will enable customers to extend their research across more applications including single-cell and exome sequencing
Released the NovaSeq S Prime (SP) flow cell (available in the fourth quarter of 2018) which is designed for smaller run sizes and/or applications that require lower sequencing output
Announced the acquisition of Edico Genome, the leading provider of data analysis acceleration solutions for next-generation sequencing (NGS)

Financial outlook and guidance

The non-GAAP financial guidance discussed below reflects certain pro forma adjustments to assist in analyzing and assessing our core operational performance. Please see our Reconciliation of Non-GAAP Financial Guidance included in this release for a reconciliation of the GAAP and non-GAAP financial measures.

For fiscal 2018, the company now projects revenue growth of approximately 20%, GAAP earnings per diluted share attributable to Illumina stockholders of $5.10 to $5.20 and non-GAAP earnings per diluted share attributable to Illumina stockholders of $5.35 to $5.45.

Quarterly conference call information

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Monday, July 30, 2018. Interested parties may access the live teleconference through the Investor Relations section of Illumina’s web site under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 800-708-4539, or 1-847-619-6396 outside North America, both with passcode 47172781.

A replay of the conference call will be available from 4:30 pm Pacific Time (7:30 pm Eastern Time) on July 30, 2018 through August 6, 2018 by dialing 888-843-7419, or 1-630-652-3042 outside North America, both with passcode 47172781.

Statement regarding use of non-GAAP financial measures

The company reports non-GAAP results for diluted net income per share, net income, gross margins, operating expenses, operating margins, other income, and free cash flow in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The company’s financial measures under GAAP include substantial charges such as amortization of acquired intangible assets, non-cash interest expense associated with the company’s convertible debt instruments that may be settled in cash, and others that are listed in the itemized reconciliations between GAAP and non-GAAP financial measures included in this press release. Management has excluded the effects of these items in non-GAAP measures to assist investors in analyzing and assessing past and future operating performance. Additionally, non-GAAP net income attributable to Illumina stockholders and diluted earnings per share attributable to Illumina stockholders are key components of the financial metrics utilized by the company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation.

The company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release.

Use of forward-looking statements

This release contains forward-looking statements that involve risks and uncertainties, including our financial outlook and guidance for fiscal 2018 and expectations regarding the development and commercialization of new products. Among the important factors that could cause actual results to differ materially from those in any forward-looking statements are: (i) challenges inherent in developing, manufacturing, and launching new products and services, including expanding manufacturing operations and reliance on third-party suppliers for critical components; (ii) the timing and mix of customer orders among our products and services; (iii) the impact of recently launched or pre-announced products and services on existing products and services; (iv) our ability to further develop and commercialize our instruments and consumables and to deploy new products, services, and applications, and expand the markets, for our technology platforms; (v) our ability to manufacture robust instrumentation and consumables; (vi) the success of products and services competitive with our own; (vii) our ability to successfully identify and integrate acquired technologies, products, or businesses; (viii) our expectations and beliefs regarding future conduct and growth of the business and the markets in which we operate; and (ix) the application of generally accepted accounting principles, which are highly complex and involve many subjective assumptions, estimates, and judgments, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts’ expectations, or to provide interim reports or updates on the progress of the current quarter.

Fate Therapeutics to Webcast Conference Call Reporting Second Quarter 2018 Financial Results

On July 30, 2018 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the Company will host a conference call and live audio webcast on Monday, August 6, 2018 at 5:00 p.m. ET to report its second quarter 2018 financial results and provide a corporate update (Press release, Fate Therapeutics, JUL 30, 2018, http://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-webcast-conference-call-reporting-second-3 [SID1234527961]).

In order to participate in the conference call, please dial 877-303-6235 (domestic) or 631-291-4837 (international) and refer to conference ID 2383816. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

Editas Medicine to Host Conference Call Discussing Second Quarter 2018 Corporate Update and Results

On July 30, 2018 Editas Medicine, Inc. (NASDAQ:EDIT), a leading genome editing company, reported that it will host a conference call and webcast on Monday, August 6, 2018, at 5:00 p.m. ET to discuss a corporate update and results for the second quarter of 2018 (Press release, Editas Medicine, JUL 30, 2018, View Source;p=RssLanding&cat=news&id=2360741 [SID1234527960]).

To access the call, please dial 844-348-3801 (domestic) or 213-358-0955 (international) and provide the passcode 4379216. A live webcast of the presentation will be available on the Investors & Media section of the Editas website.