On February 26, 2020 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported a corporate and financial update for the fourth quarter and full-year ended December 31, 2019 (Press release, G1 Therapeutics, FEB 26, 2020, View Source [SID1234554797]).

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"We achieved significant clinical and regulatory milestones across our pipeline in 2019. In 2020, our primary focus is the execution of our U.S. and European regulatory filings for trilaciclib for patients with small cell lung cancer and preparation for its commercial launch in the U.S.," said Mark Velleca, M.D., Ph.D., Chief Executive Officer. "We believe trilaciclib has the potential to improve outcomes for patients receiving chemotherapy across a broad range of tumor types. In 2020, we will initiate a Phase 3 trial in colorectal cancer and evaluate trilaciclib in the I-SPY 2 breast cancer trial."

Fourth Quarter Regulatory, Clinical and Corporate Highlights

Initiated rolling NDA submission for trilaciclib in small cell lung cancer (SCLC) in 4Q19 and expect to complete the filing in 2Q20. Certain portions of the NDA, including preclinical data, were submitted to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2019. The company plans to complete the filing in the second quarter of 2020.

Trilaciclib included in I-SPY 2 neoadjuvant breast cancer trial based on compelling overall survival (OS) findings in Phase 2 triple-negative breast cancer (TNBC) trial. At the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress, the company presented preliminary data from its randomized, open-label Phase 2 trial of trilaciclib in TNBC showing that the addition of trilaciclib to chemotherapy resulted in a significant increase in OS compared to chemotherapy alone (press release here). These findings contributed to trilaciclib being selected for inclusion in the ongoing Phase 2 I-SPY 2 TRIAL. Two new investigational treatment arms of the trial will evaluate trilaciclib in neoadjuvant treatment of locally advanced breast cancer. The study will generate data that will allow the company to evaluate trilaciclib in combination with several broadly-used chemotherapy classes, an anti-PD-1 immunotherapy, and a range of breast cancer subtypes (press release here).

Findings from Phase 1/2a rintodestrant monotherapy trial in patients with ER+, HER2- breast cancer support initiation of combination trials with CDK4/6 inhibitors. The company announced preliminary safety, tolerability and efficacy data on rintodestrant (formerly G1T48), its oral selective estrogen receptor degrader (SERD), at the 2019 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in September (press release here). Based on these findings, G1 plans to

initiate an additional arm of its ongoing Phase 1/2a trial in the second quarter of 2020 to explore the combination regimen of rintodestrant and the CDK4/6 inhibitor Ibrance (palbociclib) as a treatment for ER+, HER2- breast cancer. Palbociclib will be provided by Pfizer Inc. under a non-exclusive clinical supply agreement.

Reported additional data from Phase 1b/2a clinical trial of lerociclib in combination with fulvestrant for the treatment of ER+, HER2- breast cancer. Updated findings presented at the 2019 San Antonio Breast Cancer Symposium showed lerociclib, dosed without a drug holiday, has a differentiated safety and tolerability profile than observed in clinical trials with currently marketed CDK4/6 inhibitors. Preliminary efficacy findings were consistent with other CDK4/6 inhibitors used in combination with fulvestrant. Additional safety and efficacy data are expected in the third quarter of 2020.

Fourth Quarter/Full-Year 2019 Financial Highlights and 2020 Guidance

Cash Position: Cash and cash equivalents totaled $269.2 million as of December 31, 2019, compared to $369.3 million as of December 31, 2018.

Operating Expenses: Operating expenses were $36.6 million for the fourth quarter of 2019, compared to $26.1 million for the fourth quarter of 2018. GAAP operating expenses include stock-based compensation expense of $4.5 million for the fourth quarter of 2019, compared to $3.3 million for the fourth quarter of 2018. Operating expenses for the full-year 2019 were $129.0 million, compared to $89.3 million for the prior year. Stock-based compensation expense for the full-year 2019 was $16.4 million, compared to $10.2 million for the prior year.

Research and Development Expenses: Research and development (R&D) expenses for the fourth quarter of 2019 were $24.5 million, compared to $19.1 million for the fourth quarter of 2018. R&D expenses for the full-year 2019 were $89.0 million, compared to $70.7 million for the prior year. The increase in R&D expenses was primarily due to an increase in clinical program costs, costs for manufacturing pharmaceutical active ingredients, and personnel costs due to additional headcount.

General and Administrative Expenses: General and administrative (G&A) expenses for the fourth quarter of 2019 were $12.1 million, compared to $7.0 million for the fourth quarter of 2018. G&A expenses for the full-year 2019 were $40.0 million, compared to $18.6 million for the prior year. The increase in G&A expenses was largely due to an increase in compensation due to additional headcount, increase in pre-commercialization activities, increase in medical affairs costs, and an increase in professional fees and other administrative costs necessary to support our operations.

Net Loss: G1 reported a net loss of $35.4 million for the fourth quarter of 2019, compared to $24.1 million for the fourth quarter of 2018. Net loss for the full-year 2019 was $122.4 million, compared to a net loss of $85.3 million for the prior year.

2020 Guidance: The company expects to end 2020 with $110-$130 million in cash and cash equivalents, prior to the consideration of potential proceeds from partnerships, collaboration activities, and/or other sources of capital. The company expects year-end 2019 cash and cash equivalents of $269.2 million to be sufficient to fund its operating expenses and capital expenditure requirements into the second half of 2021.

Key Anticipated 2020 Milestones

Complete NDA submission for trilaciclib in SCLC in 2Q20 and Marketing Authorization Application to the European Medicines Agency in 4Q20.

Begin enrollment in I-SPY 2 clinical trial of trilaciclib in neoadjuvant breast cancer in 2Q20.

Initiate additional arm of rintodestrant Phase 1/2a trial to evaluate combination with Ibrance (palbociclib) in 2Q20; additional Phase 1/2a monotherapy data expected in 4Q20.

Initiate Phase 3 clinical trial of trilaciclib in colorectal cancer in 4Q20.

Webcast and Conference Call

The management team will host a webcast and conference call at 4:30 p.m. ET today to provide a corporate and financial update for the fourth quarter and full-year 2019 ended December 31, 2019. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 4188787. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

On February 26, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that it will be presenting at the Cowen and Company 40th Annual Health Care Conference on Wednesday, March 4 at 11:20 a.m. ET / 8:20 a.m. PT in Boston (Press release, Halozyme, FEB 26, 2020, View Source [SID1234554796]). Dr. Helen Torley, president and chief executive officer, will provide a corporate overview.

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The presentation will be webcast through the "Investors" section of Halozyme’s corporate website at www.halozyme.com, and a recording will be made available for 90 days following the event. To access a live webcast, please visit Halozyme’s website approximately 15 minutes prior to the presentation to register and download any necessary audio software.

On February 26, 2020 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’s management will present an overview and update, as well as host investor meetings, at the 40th Annual Cowen Health Care Conference (Press release, Supernus, FEB 26, 2020, View Source [SID1234554795]).

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Date: Monday, March 2, 2020
Time: 4:10 p.m. ET
Place: Boston Marriott Copley Place, Boston, Mass.

Investors interested in arranging a meeting with the Company’s management during this conference should contact the conference coordinator.

A live webcast of the presentation can be accessed by visiting ‘Events & Presentations’ in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay of this webcast will be available for 60 days on the Company’s website after the conference.

On February 26, 2020 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) reported its financial results for the fourth quarter and full year 2019 and recent business highlights (Press release, Ionis Pharmaceuticals, FEB 26, 2020, View Source [SID1234554792]).

"2019 was an exceptional year. We achieved our goals across the business, including advancing four medicines into pivotal studies and growing our Ionis-owned pipeline. We also made significant progress across our broad pipeline, including in our neurological and cardiometabolic disease franchises, and further advanced our antisense technology through investments in new, complementary technologies. Together these achievements position us to deliver on our goal of ten or more new drug applications through 2025," said Brett P. Monia, chief executive officer at Ionis. "This year, our priorities include further growing and advancing our Ionis-owned pipeline, initiating additional Phase 3 studies, reporting clinical proof-of-concept results from six or more studies and further developing our commercial strategy to maximize the value of each medicine in our pipeline."

2019 Financial Results and Highlights

Nearly doubled 2019 revenues, driven by SPINRAZA’s continued blockbuster performance and increasing R&D revenue

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Commercial revenue from SPINRAZA (nusinersen) royalties increased by more than 20 percent to $293 million compared to 2018

Product sales from TEGSEDI (inotersen) and WAYLIVRA (volanesorsen) were $42 million

R&D revenue more than doubled to $771 million compared to 2018

Invested in commercializing TEGSEDI and WAYLIVRA and advanced the pipeline while remaining profitable

Operating income and net income significantly improved to $366 million and $294 million, respectively, compared to 2018, on a GAAP basis

Non-GAAP operating income and net income significantly improved to $513 million and $402 million, respectively, compared to 2018

Increased cash position to $2.5 billion; further strengthened balance sheet by refinancing a significant portion of the Company’s 1 percent convertible debt due in 2021

Extended maturity to 2024, achieved 0.125 percent interest rate, and significantly increased conversion price

Returned value to shareholders by repurchasing 2 million shares of Ionis common stock in late 2019 and early 2020 for $125 million

2020 Financial Guidance

The Company’s full year 2020 financial guidance consists of the following components (on a non-GAAP basis):

Guidance

Revenue
>$700 million

Operating Expenses
~$650 million to $690 million

Meaningfully Profitable

"2019 was also an exceptional year financially, with growth in both commercial revenues and R&D revenues. We delivered over $1 billion in revenue and more than $400 million in net income. Our revenue nearly doubled compared to 2018, driven primarily by nearly $400 million in revenue from licensing AKCEA-APO(a)-LRx and AKCEA-ANGPTL3-LRx, both of which could address very large patient populations. We achieved our third consecutive year of net income while investing substantially in our pipeline and technology," said Elizabeth L. Hougen, chief financial officer of Ionis. "This year, we expect to be meaningfully profitable. We expect growth in commercial revenues, with another strong year for SPINRAZA combined with growing revenue from TEGSEDI and WAYLIVRA as we expand into new countries. We also expect to achieve important milestones as we advance our medicines in development. Our projected increase in operating expenses reflects our plan to continue investing aggressively in all aspects of our business to generate substantial value, including growing and advancing our Ionis-owned pipeline and further advancing and broadening our technology. With a 2019 year-end cash balance of $2.5 billion, we have the financial strength to fully execute on these strategic priorities."

All non-GAAP amounts referred to in this press release exclude non-cash compensation expense related to equity awards. Please refer to the reconciliation of non-GAAP and GAAP measures, which is provided later in this release.

Commercial Medicines

SPINRAZA: a global foundation-of-care for the treatment of spinal muscular atrophy (SMA) patients of all ages

Worldwide sales increased to more than $2 billion in 2019, an approximately 22 percent increase compared to 2018

Worldwide patients on treatment increased to over 10,000, including patients in commercial, early access and clinical trial settings

In the fourth quarter, patients on treatment outside the U.S. increased by approximately 10 percent, driven by growth from existing and newly launched markets

In the fourth quarter, U.S. patient growth was driven by pediatric and adult SMA patients, with adults accounting for more than 50 percent of new patient starts

Biogen initiated the Phase 2/3 DEVOTE study evaluating the safety and potential to achieve increased efficacy with a higher dose of SPINRAZA in SMA patients of all ages, including adults

TEGSEDI: launched in multiple markets for the treatment of hereditary transthyretin amyloidosis (hATTR) with polyneuropathy in adult patients

Revenue increased for each quarter during 2019, driven by growth in patients on treatment

Total units shipped to U.S. patients increased by 17 percent in the fourth quarter

Commercially available in more than ten countries

Launching in Brazil through PTC Therapeutics

Launching in additional EU countries this year

WAYLIVRA: launched in the EU as the only approved treatment for adults with genetically confirmed familial chylomicronemia syndrome (FCS) at high risk for pancreatitis

Commercial patients on therapy in Germany

Patient enrollment underway in France through the Temporary Authorization for Use (ATU)

Launching in additional EU countries this year

Potential approval in Brazil by the end of this year through PTC Therapeutics

Goal to refile for marketing authorization in the U.S. this year

Neurological Disease Franchise

Ionis-owned programs:

Initiated the Phase 3 NEURO-TTRansform study of AKCEA-TTR-LRx for the treatment of hATTR polyneuropathy

Advanced two new Ionis-owned neurological disease medicines into development:

ION716 for the treatment of Prion disease

ION283 for the treatment of Lafora disease

ION373, for the treatment of Alexander disease, granted orphan drug designation by the European Medicines Agency (EMA)

Partnered programs:

More than $55 million for licensing and advancing IONIS-MAPTRx for the treatment of Alzheimer’s disease

$10 million for advancing the Phase 1/2 study of IONIS-C9Rx for the treatment of C9ORF72-related ALS

$10 million for advancing ION581 into development for the treatment of Angelman syndrome

$30 million for advancing four new neurological disease programs toward development

Cardiometabolic Disease Franchise

Ionis-owned programs:

Initiated the Phase 3 CARDIO-TTRansform cardiovascular outcomes study of AKCEA-TTR-LRx in patients with hereditary and wild-type ATTR cardiomyopathy

AKCEA-APOCIII-LRx achieved its primary efficacy endpoint and demonstrated a favorable safety and tolerability profile in a Phase 2 proof-of-concept study

Partnered programs:

Novartis began enrolling patients in the Phase 3 HORIZON cardiovascular outcomes study of AKCEA-APO(a)-LRx in patients with established cardiovascular disease

AKCEA-ANGPTL3-LRx achieved its primary efficacy endpoint and demonstrated a favorable safety and tolerability profile in a Phase 2 proof-of-concept study

Received $250 million from Pfizer upon closing of the license agreement for the development and commercialization of AKCEA-ANGPTL3-LRx for the treatment of patients with certain cardiovascular and metabolic diseases

Key 2020 Catalysts

Initiate a Phase 3 study of AKCEA-APOCIII-LRx in patients with FCS

Report clinical proof-of-concept results from six or more studies, including IONIS-GHR-LRx, IONIS-PKK-LRx, IONIS-ENaC-2.5Rx and an orally delivered medicine

Reported positive topline results for AKCEA-APOCIII-LRx and AKCEA-ANGPTL3-LRx in January 2020

Initiate ten or more Phase 2 studies

Advance five or more new medicines into development

Revenue

Ionis’ revenue increased by more than 85 percent in 2019 compared to the same period in 2018 and was comprised of the following (amounts in millions):

Operating Expenses

Operating expenses increased for the year ended December 31, 2019, compared to the same period in 2018 principally due to Ionis’ investment in the global launch of TEGSEDI, the EU launch of WAYLIVRA and advancing medicines in the Company’s pipeline.

Loss on Early Retirement of Debt

In December 2019, Ionis refinanced a significant portion of its 1% convertible senior notes due 2021 (1% Notes) for new 0.125% convertible senior notes due 2024 (0.125% Notes). Ionis significantly reduced its interest rate, extended the maturity to December 2024 and increased the conversion price. As a result of the early refinance of the 1% Notes, Ionis recognized a $22 million non-cash loss in 2019.

Income Tax Expense (Benefit)

Ionis’ income tax expense in 2019 was primarily because the Company generated U.S. federal and state taxable income in 2019. The tax benefit in 2018 was due to a one-time non-cash tax benefit recognized in 2018 related the Company’s deferred income tax assets.

Net (Income) Loss Attributable to Noncontrolling Interest in Akcea

At December 31, 2019, Ionis owned approximately 76 percent of Akcea. The shares of Akcea third parties own represent an interest in Akcea’s equity that Ionis does not control. However, because Ionis continues to maintain overall control of Akcea through its voting interest, Ionis reflects the assets, liabilities and results of operations of Akcea in Ionis’ consolidated financial statements. Ionis reflects the noncontrolling interest attributable to other owners of Akcea’s common stock in a separate line called "Net (income) loss attributable to noncontrolling interest in Akcea" on Ionis’ statement of operations. Ionis recognized net income attributable to noncontrolling interest in Akcea in 2019 compared to a net loss in 2018. Ionis had net income attributable to noncontrolling interest in Akcea in 2019 primarily because Akcea earned significant license fee revenue from Novartis and Pfizer in 2019 which led to Akcea having net income for 2019.

Net Income Attributable to Ionis Common Stockholders

Ionis’ net income attributable to Ionis’ common stockholders and basic and diluted earnings per share increased in 2019 compared to 2018 primarily due to the significant increase in Ionis’ revenue. Somewhat offsetting this increase was income tax expense the Company recognized in 2019 compared to a one-time non-cash tax benefit recognized in 2018 related to the Company’s deferred income tax assets.

Balance Sheet

Ionis strengthened its balance sheet, ending 2019 with cash, cash equivalents and short-term investments of $2.5 billion, compared to $2.1 billion at December 31, 2018.

Webcast

Today, at 11:30 a.m. Eastern Time, Ionis will conduct a live webcast to discuss this earnings release and related activities. Interested parties may access the webcast here. A webcast replay will be available for a limited time at the same address.

On February 26, 2020 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that senior management will present at the 40th Annual Cowen Healthcare Conference on Tuesday, March 3, 2020 at 9:20 a.m. ET, being held in Boston (Press release, Coherus Biosciences, FEB 26, 2020, View Source [SID1234554790]).

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The audio portion of the presentation will be available on the investors page of the Coherus BioSciences website at View Source