Illumina Reports Financial Results for Fourth Quarter and Fiscal Year 2017

On January 30, 2018 Illumina, Inc. (NASDAQ:ILMN) reported its financial results for the fourth quarter and fiscal year 2017 (Press release, Illumina, JAN 30, 2018, View Source [SID1234523633]).

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Fourth quarter 2017 results:

Revenue of $778 million, a 26% increase compared to $619 million in the fourth quarter of 2016

GAAP net income attributable to Illumina stockholders for the quarter of $68 million, or $0.46 per diluted share, compared to $124 million, or $0.84 per diluted share, for the fourth quarter of 2016; GAAP provision for income taxes for the fourth quarter of 2017 includes our provisional estimate of the one-time transition tax as a result of U.S. tax reform

Non-GAAP net income attributable to Illumina stockholders for the quarter of $212 million, or $1.44 per diluted share, compared to $126 million, or $0.85 per diluted share, for the fourth quarter of 2016 (see the table entitled "Itemized Reconciliation Between GAAP and Non-GAAP Net Income Attributable to Illumina Stockholders" for a reconciliation of GAAP and non-GAAP financial measures)

Cash flow from operations of $294 million compared to $262 million in the fourth quarter of 2016

Free cash flow (cash flow from operations less capital expenditures) of $218 million for the quarter, compared to $180 million in the fourth quarter of 2016

Gross margin in the fourth quarter of 2017 was 69.7% compared to 67.7% in the prior year period. Excluding amortization of acquired intangible assets, non-GAAP gross margin was 70.9% for the fourth quarter of 2017 compared to 69.5% in the prior year period.

Research and development (R&D) expenses for the fourth quarter of 2017 were $137 million compared to $130 million in the prior year period. Excluding restructuring charges, non-GAAP R&D expenses as a percentage of revenue were 17.4%, including 0.7% attributable to Helix. This compares to 21.0% in the prior year period, including 2.6% attributable to GRAIL and Helix.

Selling, general and administrative (SG&A) expenses for the fourth quarter of 2017 were $175 million compared to $146 million in the prior year period. Excluding amortization of acquired intangible assets and restructuring

charges, SG&A expenses as a percentage of revenue were 22.1%, including 1.2% attributable to Helix. This compares to 23.4% in the prior year period, including 1.7% attributable to GRAIL and Helix.

Depreciation and amortization expenses were $40 million and capital expenditures for free cash flow purposes were $76 million during the fourth quarter of 2017. At the close of the quarter, the company held $2.1 billion in cash, cash equivalents and short-term investments, compared to $1.6 billion as of January 1, 2017.

Fiscal 2017 results:

Revenue of $2,752 million, a 15% increase compared to $2,398 million in fiscal 2016

GAAP net income attributable to Illumina stockholders of $726 million, or $4.92 per diluted share, compared to $463 million, or $3.07 per diluted share, in fiscal 2016; GAAP provision for income taxes for fiscal 2017 includes the provisional estimate of the one-time transition tax referenced previously

Non-GAAP net income attributable to Illumina stockholders of $591 million, or $4.00 per diluted share, compared to $503 million, or $3.33 per diluted share, in fiscal 2016 (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 $875 million compared to $779 million in fiscal 2016

Free cash flow (cash flow from operations less capital expenditures) of $565 million, compared to $519 million in fiscal 2016

Gross margin for fiscal 2017 was 66.4% compared to 69.5% in the prior year. Excluding amortization and impairment of acquired intangible assets, non-GAAP gross margin was 68.4% for fiscal 2017 compared to 71.3% in the prior year period.

Research and development (R&D) expenses for fiscal 2017 were $546 million compared to $504 million in the prior year. Excluding restructuring charges and an impairment of in-process research and development, non-GAAP R&D expenses as a percentage of revenue were 19.6%, including 1.0% attributable to GRAIL and Helix. This compares to 21.0% in the prior year period, including 1.9% attributable to GRAIL and Helix.

Selling, general and administrative (SG&A) expenses for fiscal 2017 were $674 million compared to $584 million in the prior year period. Excluding amortization of acquired intangible assets, restructuring charges, performance-based compensation related to GRAIL Series B financing, and acquisition related gain, SG&A expenses as a percentage of revenue were 23.9%, including 1.7% attributable to GRAIL and Helix. This compares to 24.0% in the prior year period, including 1.2% attributable to GRAIL and Helix.

"With 26% revenue growth in the fourth quarter, and 15% for the full year, our 2017 results demonstrate customers’ growing demand across both our sequencing and array portfolios," said Francis deSouza, President and

CEO. "From our NovaSeq and the recently launched iSeq, to our clinical portfolio that includes the VeriSeq NIPT Solution, NextSeqDx and MiSeqDx, Illumina is well-positioned to continue to drive sequencing innovation and unlock the power of the genome."

Updates since our last earnings release:

Launched the iSeqTM 100 Sequencing System, a flexible benchtop sequencer priced at $19,900 designed to provide a fast and easy-to-use system with unmatched accuracy

Announced availability of AmpliSeq for Illumina, developed in partnership with Thermo Fisher Scientific

Introduced the NextSeqTM 550Dx instrument, Illumina’s second FDA regulated CE-IVD market platform, to deliver the power of high-throughput next-generation sequencing (NGS) to the clinical laboratory

Partnered with KingMed Diagnostics to develop novel oncology and hereditary disease testing applications utilizing Illumina’s NGS technology in China

Appointed Gary S. Guthart to the company’s Board of Directors

Appointed Aimee Hoyt to the position of Senior Vice President and Chief People Officer

Repurchased $75 million of common stock in the fourth quarter under the previously announced share repurchase program

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 is projecting 13% to 14% revenue growth, GAAP earnings per diluted share attributable to Illumina stockholders of $4.14 to $4.24 and non-GAAP earnings per diluted share attributable to Illumina stockholders of $4.50 to $4.60.

Quarterly conference call information

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Tuesday, January 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 888-771-4371, or 1-847-585-4405 outside North America, both with passcode 46251622.

A replay of the conference call will be available from 4:30 pm Pacific Time (7:30 pm Eastern Time) on January 30, 2018 through February 6, 2018 by dialing 888-843-7419, or 1-630-652-3042 outside North America, both with passcode 46251622.

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, such as our financial outlook and guidance for fiscal 2018 and expectations regarding the launch 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.

Illumina Reports Financial Results for Fourth Quarter and Fiscal Year 2017

On January 30, 2018 Illumina, Inc. (NASDAQ:ILMN) reported its financial results for the fourth quarter and fiscal year 2017 (Press release, Illumina, JAN 30, 2018, View Source [SID1234523633]).

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Fourth quarter 2017 results:

Revenue of $778 million, a 26% increase compared to $619 million in the fourth quarter of 2016

GAAP net income attributable to Illumina stockholders for the quarter of $68 million, or $0.46 per diluted share, compared to $124 million, or $0.84 per diluted share, for the fourth quarter of 2016; GAAP provision for income taxes for the fourth quarter of 2017 includes our provisional estimate of the one-time transition tax as a result of U.S. tax reform

Non-GAAP net income attributable to Illumina stockholders for the quarter of $212 million, or $1.44 per diluted share, compared to $126 million, or $0.85 per diluted share, for the fourth quarter of 2016 (see the table entitled "Itemized Reconciliation Between GAAP and Non-GAAP Net Income Attributable to Illumina Stockholders" for a reconciliation of GAAP and non-GAAP financial measures)

Cash flow from operations of $294 million compared to $262 million in the fourth quarter of 2016

Free cash flow (cash flow from operations less capital expenditures) of $218 million for the quarter, compared to $180 million in the fourth quarter of 2016

Gross margin in the fourth quarter of 2017 was 69.7% compared to 67.7% in the prior year period. Excluding amortization of acquired intangible assets, non-GAAP gross margin was 70.9% for the fourth quarter of 2017 compared to 69.5% in the prior year period.

Research and development (R&D) expenses for the fourth quarter of 2017 were $137 million compared to $130 million in the prior year period. Excluding restructuring charges, non-GAAP R&D expenses as a percentage of revenue were 17.4%, including 0.7% attributable to Helix. This compares to 21.0% in the prior year period, including 2.6% attributable to GRAIL and Helix.

Selling, general and administrative (SG&A) expenses for the fourth quarter of 2017 were $175 million compared to $146 million in the prior year period. Excluding amortization of acquired intangible assets and restructuring

charges, SG&A expenses as a percentage of revenue were 22.1%, including 1.2% attributable to Helix. This compares to 23.4% in the prior year period, including 1.7% attributable to GRAIL and Helix.

Depreciation and amortization expenses were $40 million and capital expenditures for free cash flow purposes were $76 million during the fourth quarter of 2017. At the close of the quarter, the company held $2.1 billion in cash, cash equivalents and short-term investments, compared to $1.6 billion as of January 1, 2017.

Fiscal 2017 results:

Revenue of $2,752 million, a 15% increase compared to $2,398 million in fiscal 2016

GAAP net income attributable to Illumina stockholders of $726 million, or $4.92 per diluted share, compared to $463 million, or $3.07 per diluted share, in fiscal 2016; GAAP provision for income taxes for fiscal 2017 includes the provisional estimate of the one-time transition tax referenced previously

Non-GAAP net income attributable to Illumina stockholders of $591 million, or $4.00 per diluted share, compared to $503 million, or $3.33 per diluted share, in fiscal 2016 (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 $875 million compared to $779 million in fiscal 2016

Free cash flow (cash flow from operations less capital expenditures) of $565 million, compared to $519 million in fiscal 2016

Gross margin for fiscal 2017 was 66.4% compared to 69.5% in the prior year. Excluding amortization and impairment of acquired intangible assets, non-GAAP gross margin was 68.4% for fiscal 2017 compared to 71.3% in the prior year period.

Research and development (R&D) expenses for fiscal 2017 were $546 million compared to $504 million in the prior year. Excluding restructuring charges and an impairment of in-process research and development, non-GAAP R&D expenses as a percentage of revenue were 19.6%, including 1.0% attributable to GRAIL and Helix. This compares to 21.0% in the prior year period, including 1.9% attributable to GRAIL and Helix.

Selling, general and administrative (SG&A) expenses for fiscal 2017 were $674 million compared to $584 million in the prior year period. Excluding amortization of acquired intangible assets, restructuring charges, performance-based compensation related to GRAIL Series B financing, and acquisition related gain, SG&A expenses as a percentage of revenue were 23.9%, including 1.7% attributable to GRAIL and Helix. This compares to 24.0% in the prior year period, including 1.2% attributable to GRAIL and Helix.

"With 26% revenue growth in the fourth quarter, and 15% for the full year, our 2017 results demonstrate customers’ growing demand across both our sequencing and array portfolios," said Francis deSouza, President and

CEO. "From our NovaSeq and the recently launched iSeq, to our clinical portfolio that includes the VeriSeq NIPT Solution, NextSeqDx and MiSeqDx, Illumina is well-positioned to continue to drive sequencing innovation and unlock the power of the genome."

Updates since our last earnings release:

Launched the iSeqTM 100 Sequencing System, a flexible benchtop sequencer priced at $19,900 designed to provide a fast and easy-to-use system with unmatched accuracy

Announced availability of AmpliSeq for Illumina, developed in partnership with Thermo Fisher Scientific

Introduced the NextSeqTM 550Dx instrument, Illumina’s second FDA regulated CE-IVD market platform, to deliver the power of high-throughput next-generation sequencing (NGS) to the clinical laboratory

Partnered with KingMed Diagnostics to develop novel oncology and hereditary disease testing applications utilizing Illumina’s NGS technology in China

Appointed Gary S. Guthart to the company’s Board of Directors

Appointed Aimee Hoyt to the position of Senior Vice President and Chief People Officer

Repurchased $75 million of common stock in the fourth quarter under the previously announced share repurchase program

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 is projecting 13% to 14% revenue growth, GAAP earnings per diluted share attributable to Illumina stockholders of $4.14 to $4.24 and non-GAAP earnings per diluted share attributable to Illumina stockholders of $4.50 to $4.60.

Quarterly conference call information

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Tuesday, January 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 888-771-4371, or 1-847-585-4405 outside North America, both with passcode 46251622.

A replay of the conference call will be available from 4:30 pm Pacific Time (7:30 pm Eastern Time) on January 30, 2018 through February 6, 2018 by dialing 888-843-7419, or 1-630-652-3042 outside North America, both with passcode 46251622.

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, such as our financial outlook and guidance for fiscal 2018 and expectations regarding the launch 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.

Array BioPharma To Report Financial Results For The Second Quarter Of Fiscal 2018 On February 6, 2018

On January 30, 2018 Array BioPharma Inc. (Nasdaq: ARRY) will report its financial results for the second quarter of fiscal 2018 and hold a conference call to discuss those results on Tuesday, February 6, 2018 (Press release, Array BioPharma, JAN 30, 2018, View Source;p=RssLanding&cat=news&id=2329146 [SID1234523632]). Ron Squarer, Chief Executive Officer, will lead the call.

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Date: Tuesday, February 6, 2018

Time: 9:00 a.m. Eastern Time

Toll-Free: (844) 464-3927

Toll: (765) 507-2598

Pass Code: 6187887

Webcast, including Replay and Conference Call Slides:
View Source

Heat Biologics to Host Analyst and Investor Event February 28, 2018 to Present Results from its Phase 2 Lung Cancer Study

On January 30, 2018 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer reported that it is hosting an analyst and investor event to present Phase 2 results from its HS-110 (viagenpumatucel-L) study in combination with the Bristol-Myers Squibb checkpoint inhibitor, nivolumab (Opdivo), in patients with advanced non-small cell lung cancer (NSCLC) whose cancers have progressed after treatment with one or more lines of therapy (Press release, Heat Biologics, JAN 30, 2018, View Source [SID1234523629]).

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

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The presentation will take place at 8 a.m., Wednesday, Feb. 28, 2018, in New York City. A live webcast will be available for those who cannot attend. The event will follow the first formalized Independent Data Monitoring Committee ("IDMC") meeting review of the most recent Phase 2 interim data from the trial.

"We are looking forward to concluding our first IDMC data review and presenting our initial Phase 2 results," said Jeff Wolf, CEO of Heat. "Our presentation will focus on clinical observations, which will help inform the best pathway to advance HS-110 through a registrational trial."

The presentation will include data generated from the first 35 patients enrolled in the study; specifically:

Clinical efficacy measures of treatment response
The correlation of immune response from blood samples with positive clinical outcome
Safety data evaluation and analysis
Key opinion leaders will also provide an overview of NSCLC and the need for combination therapies in this setting, while management will discuss company milestones for 2018 and beyond. Further, management will provide an outline of Heat’s planned development strategy for HS-110 based on the recent outcome of its Type C meeting with the FDA.

Additional details such as location, speakers and webcast information will be provided prior to the event.

TrakCel and WindMIL Therapeutics partner on cell therapy supply chain management and orchestration platform

On January 29, 2018 TrakCel, the software developer for cell and gene therapy supply chain tracking and orchestration systems, and WindMIL Therapeutics, a clinical stage oncology cell therapy company leveraging a proprietary platform to develop a novel class of cell therapies called MILs (Marrow Infiltrating Lymphocytes), reported they have partnered to build a custom-configured cellular supply chain tracking and orchestration platform to support clinical development of proprietary autologous cell therapies by WindMIL (Press release, TrakCel, JAN 29, 2018, View Source [SID1234553992]).

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The supply chain platform will be used to manage WindMIL’s entire supply chain as WindMIL expands its program of cell therapy clinical trials later this year. This expansion of clinical trials follows WindMIL’s completion of a $32.5 million Series B fundraising in June 2018. WindMIL’s unique expertise in bone marrow immunology includes the only replicable and scalable process to create a cell therapy product from bone marrow-derived T cells, which are naturally tumor specific and of a memory phenotype.

The TrakCel platform will be live in over 100 sites globally by Q1 2019. This will enable WindMIL to leverage clinical site familiarity with the platform, while ensuring connectivity across all organizations and professionals involved. The system will harmonize with all partner internal systems, including those of clinical sites, couriers, CROs and CMOs. This will support an efficient and well controlled supply chain that makes the precision of collection, transportation and manufacturing visible to all involved. It also will encompass a specifically designed
interface for physicians and medical teams.

"We are excited to soon treat more patients with MILs through this expansion of our clinical trial program. MILs harness the power of the body’s own immune system, specifically cells residing in the bone marrow. We are the only company focused on manufacturing and developing this natural source of tumor-targeting, central-memory T cells," said Brian Halak, President and CEO, WindMIL
Therapeutics. "However, developing novel cellular therapies is also about logistics. It is important for us to ensure the supply chain works for each of the individuals involved in the patient’s care and for the oncology patients themselves. We wanted to appoint a company that we saw as a partner, capable of delivering a supply chain solution that is essential for clinical success. TrakCel had the expertise and experience to achieve this."

"The entire cell therapy sector now realizes the importance of managing and tracking the supply chain from an early stage. As a result, TrakCel is now working with a range of companies at the initiation of the clinical stage as well as at the late stage of clinical development," said Ravi Nalliah, CEO of TrakCel. "The opportunity cost of the resources used for managing supply chains is even more important for companies at the earlier clinical stage. This means it is essential for TrakCel to continue to develop our cell therapy supply chain solutions as the cell therapy market continues to evolve."