Supernus to Host Third Quarter 2019 Earnings Conference Call

On October 24, 2019 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Company expects to report business results for the third quarter of 2019 after 5:00 p.m. ET on Tuesday, November 5, 2019 (Press release, Supernus, OCT 24, 2019, View Source [SID1234542493]).

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Jack Khattar, President and Chief Executive Officer, and Greg Patrick, Chief Financial Officer, will host a conference call to present the third quarter 2019 business and financial results on Wednesday, November 6, 2019 at 9:00 a.m. ET. Following management’s prepared analysis and discussion of business results, the call will be open for questions.

A live webcast will be available at www.supernus.com.

Please refer to the information below for conference call dial-in information. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference dial-in: (877) 288-1043
International dial-in: (970) 315-0267
Conference ID: 8278897
Conference Call Name: Supernus Pharmaceuticals Third Quarter 2019 Earnings Conference Call
Following the live call, a replay will be available on the Company’s website under the ‘Investors Relations’ section. The webcast will be available on the Company’s website for 60 days following the live call.

Pfenex to Announce Third Quarter 2019 Financial Results on November 7th

On October 24, 2019 Pfenex Inc. (NYSE American: PFNX), a development and licensing biotechnology company focused on leveraging its Pfēnex Expression Technology to develop and improve protein therapies for unmet patient needs, reported that it will report its financial results for the third quarter 2019, after the market close on Thursday, November 7, 2019 (Press release, Pfenex, OCT 24, 2019, View Source [SID1234542492]).

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The Company will host a conference call to discuss financial results and general business updates at 4:30 PM Eastern Time on Thursday, November 7, 2019.

Conference Call & Webcast
Thursday, November 7th @ 4:30pm Eastern Time/1:30pm Pacific Time
Domestic: 866-376-8058
International: 412-542-4131
Webcast: View Source

Replays available through November 14th:
Domestic: 877-344-7529
International: 412-317-0088
Replay Access Code: 10136405

Illumina Reports Financial Results for Third Quarter of Fiscal Year 2019

On October 24, 2019 Illumina, Inc. (NASDAQ: ILMN) reported its financial results for the third quarter of fiscal year 2019 (Press release, Illumina, OCT 24, 2019, View Source [SID1234542491]).

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Third quarter 2019 results:

•Revenue of $907 million, a 6% increase compared to $853 million in the third quarter of 2018
•GAAP net income attributable to Illumina stockholders for the quarter of $234 million, or $1.58 per diluted share, compared to $199 million, or $1.33 per diluted share, for the third quarter of 2018
•Non-GAAP net income attributable to Illumina stockholders for the quarter of $286 million, or $1.93 per diluted share, compared to $227 million, or $1.52 per diluted share, for the third quarter of 2018. Non-GAAP net income excludes an unrealized net loss of $43 million from mark-to-market adjustments on our strategic investments, primarily from our marketable equity securities (see the table entitled "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 $267 million compared to $292 million in the third quarter of 2018
•Free cash flow (cash flow from operations less capital expenditures) of $218 million for the quarter compared to $228 million in the third quarter of 2018

Gross margin in the third quarter of 2019 was 71.5% compared to 70.0% in the prior year period. Excluding amortization of acquired intangible assets, non-GAAP gross margin was 72.5% for the third quarter of 2019 compared to 71.1% in the prior year period.

Research and development (R&D) expenses for the third quarter of 2019 were $151 million compared to $159 million in the prior year period. Excluding restructuring charges, non-GAAP R&D expenses as a percentage of revenue were 16.4% compared to 18.6% in the prior year period.

Selling, general and administrative (SG&A) expenses for the third quarter of 2019 were $189 million compared to $197 million in the prior year period. Excluding acquisition-related expenses and restructuring charges, non-GAAP SG&A expenses as a percentage of revenue were 20.0% compared to 23.2% in the prior year period.

Depreciation and amortization expenses were $47 million and capital expenditures for free cash flow purposes were $49 million during the third quarter of 2019. At the close of the quarter, the company held $3.2 billion in cash, cash equivalents and short-term investments, compared to $3.5 billion as of December 30, 2018.

"This was a solid quarter for Illumina, with product revenue in-line with expectations, and a stronger than expected revenue contribution associated with partner collaborations to develop distributable clinical IVDs for Illumina sequencers," said Francis deSouza, President and CEO. "Third quarter NovaSeq system shipments represented the second highest since launch, and included capacity expansion to support the UK Biobank initiative to sequence 450,000 whole genomes over the next several years. Additionally, continued NovaSeq adoption resulted in the highest consumables pull-through quarter for the platform this year."

Updates since our last earnings release:

•Partnered with QIAGEN to develop and commercialize a portfolio of IVD test kits for use on Illumina Dx sequencing instruments, broadening clinical access to NGS-based IVD tests
•Partnered with Adaptive Biotechnologies to develop distributable IVD test kits for clonoSEQ and immunoSEQ Dx on Illumina’s NextSeq 550Dx system
•Announced a collaboration with the Broad Institute to co-develop open-source genomic secondary analysis tools that will broaden access to best-in-class variant calling algorithms
•Submitted the first module of the Premarket Approval (PMA) submission to the FDA for TruSight Comprehensive Assay, the IVD version of our RUO TruSight Oncology 500
•Extended the merger agreement with Pacific Biosciences to December 31, 2019 with an option to extend the deadline to March 31, 2020
•Repurchased $199 million of outstanding common stock in the third quarter under the previously announced share repurchase program, which has a remaining balance of approximately $289 million as of September 29, 2019
•Welcomed Joydeep Goswami as Senior Vice President of Corporate Development and Strategic Planning

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 2019, the company continues to expect year over year revenue growth of approximately 6%, and now expects GAAP earnings per diluted share attributable to Illumina stockholders of $6.55 to $6.60 and non-GAAP earnings per diluted share attributable to Illumina stockholders of $6.40 to $6.45.

Except for acquisition-related expenses incurred during the first three quarters of 2019 which are reflected in our GAAP guidance, this guidance excludes any impact from the pending acquisition of Pacific Biosciences.

Quarterly conference call information

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Thursday, October 24, 2019. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website under the "Company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1 (866) 211-4597 or 1 (647) 689-6853 outside North America, both with conference ID 2388693.

Lilly Announces Cash Tender Offer for Up to $2.0 Billion Aggregate Principal Amount of Its Outstanding Debt Securities

On October 24, 2019 Eli Lilly and Company (NYSE: LLY) reported that it has commenced a cash tender offer for up to $2.0 billion aggregate principal amount (the "tender cap") of specified series of its outstanding debt (Press release, Eli Lilly, OCT 24, 2019, View Source [SID1234542490]). Pursuant to the tender offer, Lilly is offering to purchase, under certain conditions and subject to certain limitations, its 3.950% Notes due 2047, 3.700% Notes due 2045, 3.875% Notes due 2039, 7.125% Notes due 2025, 6.77% Notes due 2036, 5.950% Notes due 2037, 5.55% Notes due 2037, 5.50% Notes due 2027, 4.650% Notes due 2044, 3.100% Notes due 2027, 2.750% Notes due 2025, 3.375% Notes due 2029, 3.950% Notes due 2049, 4.150% Notes due 2059 and 2.350% Notes due 2022 (collectively, the "notes").

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The early tender date is 5:00 p.m., New York City time, on November 6, 2019, unless extended. The expiration date of the tender offer is 11:59 p.m., New York City time, on November 21, 2019, unless extended or earlier terminated. The terms, conditions and limitations of the tender offer are described in the Offer to Purchase dated as of today’s date.

Holders of notes must validly tender and not validly withdraw their notes before the early tender date to be eligible to receive the total consideration (as described below). Tendered notes may only be withdrawn prior to 5:00 p.m., New York City time, on November 6, 2019. Notes tendered after the withdrawal date and before the expiration date may not be withdrawn, except in certain limited circumstances where additional withdrawal rights are required by law.

Subject to the tender cap, tendered notes will be accepted in the order of the acceptance priority levels set forth in the table above, except that the aggregate principal amount of the 3.950% Notes due 2049 accepted will not exceed the 3.95% note cap, the aggregate principal amount of the 4.150% Notes due 2049 accepted will not exceed the 4.15% note cap, and the aggregate principal amount of the 2.350% Notes due 2022 accepted will not exceed the 2.35% note cap. Lilly reserves the right, but is not obligated, to increase the tender cap or the note caps. Tenders of 3.950% Notes due 2047, 3.875% Notes 2039, 3.700% Notes due 2045, 5.950% Notes due 2037, 5.50% Notes due 2027, 5.55% Notes due 2037, 4.650% Notes due 2044, 3.100% Notes due 2027, 2.750% Notes due 2025, 3.375% Notes due 2029, 3.950% Notes due 2049, 4.150% Notes due 2059 and 2.350% Notes due 2022 will be accepted only in principal amounts equal to $2,000 and integral multiples of $1,000 in excess thereof. Tenders of 6.77% Notes due 2036 and 7.125% Notes due 2025 will be accepted only in principal amounts equal to $1,000 and integral multiples thereof.

The total consideration for each $1,000 principal amount of notes tendered and accepted for payment by Lilly pursuant to the tender offer will be determined in the manner described in the Offer to Purchase by reference to a fixed spread specified in the table above for each series of the notes and over the yield based on the bid-side price of the U.S. Treasury Security specified in the table above, as calculated by Citigroup Global Markets Inc., Morgan Stanley & Co. LLC, BNP Paribas Securities Corp. and J.P. Morgan Securities LLC for the tender offer at 10:00 a.m., New York City time, on November 7, 2019. Holders of notes who validly tender their notes after the early tender date will, if such notes are accepted by Lilly, receive the tender consideration, which is equal to the total consideration minus $30 per $1,000 principal amount of notes tendered by such holders and accepted for purchase by Lilly. Accrued and unpaid interest up to, but excluding, the applicable settlement date will be paid in cash on all validly tendered notes accepted and purchased by Lilly in the tender offer.

Lilly reserves the right, but is under no obligation, at any point following the early tender date and before the expiration date of the tender offer, to accept for purchase any notes validly tendered (and not validly withdrawn) at or prior to the early tender date. The initial settlement date will be determined at Lilly’s option and is currently expected to occur on November 8, 2019. Regardless of whether Lilly chooses to exercise its option to have an initial settlement date, Lilly will purchase any remaining notes that have been validly tendered (and not validly withdrawn) by the expiration date of the tender offer and accepted for purchase (subject to the tender cap, the note caps, and the application of the acceptance priority levels), promptly following the expiration date of the tender offer.

All notes validly tendered and not validly withdrawn before the early tender date having a higher acceptance priority level will be accepted (subject to the tender cap and the note caps) before any tendered notes having a lower acceptance priority level, and all notes validly tendered after the early tender date having a higher acceptance priority level will be accepted (subject to the tender cap and the note caps) before any notes tendered after the early tender date having a lower acceptance priority level. However, notes validly tendered and not validly withdrawn on or before the early tender date will be accepted for purchase (subject to the tender cap and the note caps) in priority to other notes tendered after the early tender date, even if such notes tendered after the early tender date have a higher acceptance priority level than notes tendered prior to the early tender date.

Notes accepted for purchase in accordance with the terms and conditions of the tender offer may be subject to proration (rounded down to avoid the purchase of notes in a principal amount other than in integral multiples of $1,000), so that Lilly will only accept for purchase notes in an aggregate principal amount up to the tender cap, including the maximum amount of 3.950% Notes due 2049 that may be purchased pursuant to the 3.95% note cap, 4.150% Notes due 2059 that may be purchased pursuant to the 4.15% note cap, and 2.350% Notes due 2022 that may be purchased pursuant to the 2.35% note cap. If purchasing all of the tendered notes of a series of notes of an applicable acceptance priority level on any settlement date would cause the tender cap and the note caps to be exceeded, the amount of that series of notes purchased on that settlement date will be prorated based on the aggregate principal amount of that series of notes tendered in respect of that settlement date such that the tender cap and the note caps will not be exceeded. Furthermore, if the tender offer is fully subscribed as of the early tender date, holders who validly tender notes after the early tender date will not have their notes accepted for payment.

The offer for each series of notes is conditioned upon the satisfaction of certain conditions, including the completion of an offering of debt securities by Lilly on terms and conditions satisfactory to Lilly that results in the receipt of net proceeds that, when taken together with cash on hand, is sufficient to pay the consideration for all tendered notes validly tendered (and not validly withdrawn) and accepted for purchase by Lilly, plus related accrued and unpaid interest and fees and expenses. The offer is not conditioned on a minimum principal amount of notes being tendered nor the consummation of any other offer. The offer with respect to one or more series of the notes may be amended, extended, terminated or withdrawn separately.

Lilly has retained Citigroup Global Markets Inc. and Morgan Stanley & Co. LLC to serve as lead dealer managers for the tender offer and BNP Paribas Securities Corp. and J.P. Morgan Securities LLC to serve as co-dealer managers. Lilly has retained Global Bondholder Services Corporation to serve as tender agent and information agent for the tender offer.

Requests for documents relating to the tender offer may be directed to Global Bondholder Services Corporation by telephone at (866) 470-3900, by email at [email protected] or in writing at 65 Broadway, Suite 404, New York, NY 10006. Questions regarding the tender offer may be directed to Citigroup Global Markets Inc. at (212) 723-6106 or to Morgan Stanley & Co. LLC at (800) 624-1808.

This press release is for informational purposes only and is not a tender offer to purchase or a solicitation of acceptance of a tender offer, which may be made only pursuant to the terms of the Offer to Purchase. In any jurisdiction where the laws require the tender offer to be made by a licensed broker or dealer, the tender offer will be deemed made on behalf of Lilly by the dealer managers, or one or more registered brokers or dealers under the laws of such jurisdiction. In addition, this press release is not an offer to sell or the solicitation of an offer to buy any securities. No offer, solicitation, purchase or sale will be made in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. Any such securities will be offered only by means of a prospectus, including a prospectus supplement relating to such securities, meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Syros Announces New Data from Phase 2 Trial of SY-1425 in Combination with Azacitidine Demonstrating High Response Rates, Rapid Onset of Action and Favorable Tolerability Profile in RARA-Positive Newly Diagnosed Unfit AML Patients

On October 24, 2019 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported that updated clinical data from its ongoing Phase 2 trial evaluating SY-1425, its first-in-class selective retinoic acid receptor alpha (RARα) agonist, in combination with azacitidine, continue to demonstrate high complete response rates, rapid onset of action and a favorable tolerability profile in a genomically defined subset of newly diagnosed acute myeloid leukemia (AML) patients who are not suitable candidates for standard intensive chemotherapy (Press release, Syros Pharmaceuticals, OCT 24, 2019, View Source [SID1234542486]). These data are being presented at the European School of Haematology (ESH) 5th International Conference Acute Myeloid Leukemia "Molecular and Translational": Advances in Biology and Treatment in Estoril, Portugal.

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"I am very encouraged by these data. AML patients continue to need new treatment options, despite recent advances in the field, that are well-tolerated and can be used in combination to extend survival and improve quality of life," said Stéphane de Botton, M.D., Head of Acute Myeloid Malignancies at Institut Gustave Roussy and a clinical investigator in the Phase 2 trial of SY-1425. "These data show that SY-1425, a targeted therapy, in combination with azacitidine is highly active in a subset of patients that can be readily identified and that the combination is generally well-tolerated even in very sick AML patients. I believe SY-1425 is a promising combination agent with the potential to provide a meaningful benefit for a subset of AML patients, and I look forward to its continued development."

"These data mark an important milestone in the development of SY-1425," said David A. Roth, M.D., Chief Medical Officer of Syros. "SY-1425 in combination with azacitidine continues to demonstrate high complete response rates, rapid onset of action and a favorable tolerability profile in RARA-positive AML patients. As we study the combination in more patients, we are also seeing a high rate of transfusion independence and early evidence of durable responses. We are gratified to see our discovery of this novel patient subset, as defined by our RARA biomarker, translating into clinical benefit. These results demonstrate the power of our gene control platform to identify which genes to modulate in which patients to maximize the chances of providing them with a profound benefit. We look forward to continuing to evaluate SY-1425 in our ongoing study and to reporting potential proof-of-concept data next year in RARA-positive relapsed or refractory AML patients."

Updated Clinical Data on SY-1425 in Combination with Azacitidine in Newly Diagnosed, Unfit AML Patients

Syros presented updated data from its Phase 2 trial of SY-1425 in combination with azacitidine, a standard-of-care hypomethylating agent, in newly diagnosed unfit AML patients. The trial evaluated the safety and efficacy of the combination in patients with either the RARA or IRF8 biomarker, as well as in patients without the biomarkers. All patients were treated with azacitidine administered at standard daily doses of 75 mg/m2 intravenously or subcutaneously for seven days, followed by SY-1425 administered at 6 mg/m2/day orally, divided in two doses, for the remainder of each 28-day cycle.

As of Aug. 22, 2019, 40 newly diagnosed unfit AML patients had been enrolled in the trial and were eligible for the safety analysis. The median age of patients enrolled in the study was 76. Of the 17 biomarker-positive patients evaluable for response, 13 were RARA-positive and four were IRF8-positive. Enrollment in the newly diagnosed unfit cohorts of the ongoing Phase 2 trial is nearly complete. Syros will continue to follow patients enrolled in the trial to further characterize the overall profile of the combination, including safety, efficacy and durability of response.

Clinical Activity Data

62% complete response (CR) and complete response with incomplete blood count recovery (CRi) rate, as defined by Revised International Working Group, IWG, criteria), in RARA-positive patients.

54% CR rate in RARA-positive patients, consisting of seven CRs, including three molecular CRs and three cytogenetic CRs.

Most initial responses were seen at the first response assessment.

Duration of these responses in RARA-positive patients was up to 344 days, with three of the eight responding patients having responses lasting beyond seven months at the time of the data cutoff.

82% of RARA-positive patients achieved or maintained transfusion independence.

Responses were seen in RARA-positive patients across AML risk groups, including patients with mutations that are typically associated with poor outcomes.

In patients with only the IRF8-biomarker, the CR/CRi rate was 0%, supporting Syros’ decision to use RARA as the sole biomarker for patient selection in SY-1425 clinical trials going forward. Based on data from 112 newly diagnosed patients screened for its clinical trial, Syros believes that approximately 30% of newly diagnosed AML patients are RARA-positive.

In the 22 response-evaluable RARA-negative patients, the CR/CRi rate was 27%, which is consistent with the published response rates of 18-29% observed in newly diagnosed unfit AML patients treated with single-agent azacitidine.

Safety Data

SY-1425 in combination with azacitidine was generally well-tolerated with no evidence of increased toxicities beyond what is seen with either SY-1425 or azacitidine alone.

Rates of myelosuppression, including neutropenia, were comparable to reports of single-agent azacitidine in this AML population.

The majority of non-hematologic AEs were low grade.

Across all grades and causalities, the most commonly reported AEs were nausea (38%), decreased appetite (38%), constipation (33%), fatigue (33%) and peripheral edema (30%).

The most commonly reported Grade 3 or higher AEs (all causality) were thrombocytopenia (25%), anemia (23%), and febrile neutropenia (23%).

The poster presented at ESH is now available on the Publications and Abstracts section of the Syros website at www.syros.com.

The ongoing Phase 2 trial is actively enrolling patients with relapsed or refractory AML patients who are positive for the RARA biomarker. Syros expects to report potential proof-of-concept from the cohort in relapsed or refractory AML patients in 2020. Additional details about the Phase 2 trial of SY-1425 can be found using the identifier NCT02807558 at www.clinicaltrials.gov.