GlycoMimetics to Report Third Quarter 2019 Financial Results on November 7, 2019

On October 31, 2019 GlycoMimetics, Inc. (NASDAQ: GLYC) reported that it will host a conference call and webcast to report its third-quarter 2019 financial results on Thursday, November 7, 2019, at 8:30 a.m. ET (Press release, GlycoMimetics, OCT 31, 2019, View Source [SID1234550121]).

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The dial-in number for the conference call is (844) 413-7154 (U.S. and Canada) or (216) 562-0466 (international) and entering passcode 9845948. To access the live audio webcast, or the subsequent archived recording, visit the "Investors – Events & Presentations" section of the GlycoMimetics website at www.glycomimetics.com. The webcast will be recorded and available for replay on the GlycoMimetics website for 30 days following the call.

Myovant Sciences Enters Landmark Agreement with Sumitomo Dainippon Pharma to Secure Major Financial Backing and Safeguards for Minority Shareholder

On October 31, 2019 Myovant Sciences (NYSE: MYOV), a healthcare company focused on developing innovative treatments for women’s health and prostate cancer, reported that it has entered into a landmark agreement with Sumitomo Dainippon Pharma Co., Ltd. (TSE: 4506), a leading Japanese pharmaceutical company, on a $350 million low-interest, five-year term loan facility and an Investor Rights Agreement (Press release, Myovant Sciences, OCT 31, 2019, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-enters-landmark-agreement-sumitomo-dainippon [SID1234550137]). This agreement was made in conjunction with Myovant’s founding shareholder, Roivant Sciences, and Sumitomo Dainippon Pharma entering into a definitive agreement for the creation of a broad strategic alliance. At closing, the alliance entity will assume Roivant’s ownership interest in Myovant, which is expected to represent not less than a majority of Myovant’s outstanding shares.

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"Sumitomo Dainippon Pharma is committed to supporting Myovant through commercialization and profitability as the robust potential of relugolix is unlocked for women with uterine fibroids or endometriosis, and for men with prostate cancer," said Hiroshi Nomura, Representative Director, President and CEO of Sumitomo Dainippon Pharma.

"Myovant is delighted to have the support of Sumitomo Dainippon Pharma," said Lynn Seely, M.D., President and CEO of Myovant. "With total cash and committed financing of approximately $500 million, including the Sumitomo Dainippon Pharma term loan facility, we will be in a strong financial position to advance the commercialization of relugolix."

Sumitomo Dainippon Pharma has committed to provide Myovant a $350 million low-interest, five-year term loan facility, with no repayments due until the end of the term to fund Myovant’s operating expenditures. Myovant will be able to access the facility on a quarterly basis, subject to certain terms and conditions. The agreement will become effective upon close of the Sumitomo Dainippon Pharma transaction with Roivant.

Myovant and Sumitomo Dainippon Pharma will also enter into an Investor Rights Agreement, which provides that the Myovant Board of Directors will continue to include a minimum of three independent directors who will have approval rights over certain corporate actions, including related-party transactions between Myovant and Sumitomo Dainippon Pharma. The ratio of independent to non-independent directors is also expected to remain unchanged. The Investor Rights Agreement will further include standstill provisions including a non-waivable condition requiring approval by a majority of the minority shareholders for any transaction that would cause Sumitomo Dainippon Pharma to hold beneficial ownership of Myovant of greater than 60%. Additionally, for a standstill period of three years, any such transaction must also be made on a confidential basis to the independent directors and is subject to approval by a majority of the independent directors.

Subject to the closing of the strategic alliance transaction, Sumitomo Dainippon Pharma has also agreed that upon Myovant’s request, the parties will discuss terms upon which Sumitomo Dainippon Pharma will provide Myovant access to its U.S. commercial infrastructure and operational support as Myovant moves forward with the commercialization of relugolix.

Earlier this year, Myovant announced positive topline data from two Phase 3 studies, LIBERTY 1 and LIBERTY 2, evaluating relugolix combination therapy in women with uterine fibroids, as well as positive results from a separate bioequivalence study supporting a potential one pill, once-a-day dosing regimen of relugolix combination therapy. Myovant expects to announce topline results from its Phase 3 study, HERO, evaluating relugolix monotherapy in men with advanced prostate cancer later this year and results from two Phase 3 studies, SPIRIT 1 and SPIRIT 2, evaluating relugolix combination therapy in women with endometriosis in the first and second quarters of 2020.

Amgen Enters Into Strategic Collaboration With BeiGene To Expand Oncology Presence In China

On October 31, 2019 Amgen (NASDAQ:AMGN) reported that it has entered into a strategic collaboration with BeiGene that will significantly accelerate Amgen’s plans to expand its oncology presence in China, the world’s second-largest pharmaceutical market (Press release, Amgen, OCT 31, 2019, View Source [SID1234550153]). BeiGene is a research-based, oncology-focused biotechnology company with an established and highly experienced team in China, including a 700-person commercial organization and a 600-person clinical development organization.

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"This strategic collaboration with BeiGene will enable Amgen to serve significantly more patients by expanding our presence in the world’s most populous country," said Robert A. Bradway, Amgen’s chairman and chief executive officer. "Cancer is a leading cause of death in China and will only become a more pressing public health issue as the Chinese population ages. With its extensive commercial and clinical capabilities within China and a commitment to global quality standards, BeiGene is the ideal strategic collaborator as we seek to make a meaningful difference in the lives of millions of cancer patients in China and around the world."

As part of the collaboration:

Amgen will acquire a 20.5% stake in BeiGene for approximately $2.7 billion in cash. This represents a purchase price of $174.85 per BeiGene American Depositary Share on NASDAQ, a 36% premium to BeiGene’s 30-day volume-weighted average share price as of Oct. 30, 2019. Amgen will nominate one person to serve on BeiGene’s Board of Directors.
Under the agreement, BeiGene will commercialize XGEVA (denosumab), KYPROLIS (carfilzomib) and BLINCYTO (blinatumomab) in China during which time the parties will equally share profits and losses. Two of these products will revert to Amgen, one after five years and one after seven years. Following the commercialization period, BeiGene will have the right to retain one product and will be entitled to receive royalties on sales in China for an additional five years on the products not retained. XGEVA was launched in China in September of this year; KYPROLIS and BLINCYTO are both in Phase 3 trials in China.
Amgen and BeiGene will collaborate to advance 20 medicines from Amgen’s innovative oncology pipeline in China and globally. BeiGene will share global research and development costs and contribute up to $1.25 billion to advance these medicines. Amgen will pay royalties to BeiGene on the sales of these products outside of China, with the exception of AMG 510, Amgen’s first-in-class KRASG12C inhibitor that is being studied as a potential treatment for solid tumors. Amgen anticipates utilizing data from clinical trials conducted in China to advance the development of its oncology portfolio globally.
Of the 20 oncology medicines in development, BeiGene will assume commercial rights in China for seven years after launch for those that receive approval in China, including AMG 510. After this time, BeiGene will retain rights to up to six of these products in China, excluding AMG 510, while rights on remaining products revert to Amgen. Amgen and BeiGene will share profits in China equally on these products until the rights revert to Amgen, after which Amgen will pay royalties to BeiGene on sales in China for a period of five years after reversion.
Amgen will continue to commercialize its non-oncology product portfolio in China. Earlier this year, Amgen launched its first-ever product in China, Repatha (evolocumab), an LDL cholesterol-lowering treatment proven to reduce the risk of heart attacks and stroke. Amgen expects to launch a number of other non-oncology medicines in China over the next several years, including Prolia (denosumab), which reduces the risk of fracture in postmenopausal women with osteoporosis.
XGEVA, KYPROLIS and BLINCYTO, as well as the medicines in Amgen’s oncology pipeline, will be manufactured at Amgen’s existing facilities.
Since 2011, Amgen has expanded its geographic presence from approximately 50 to 100 countries, enabling the company to play a growing role in serving the rapidly increasing demand for better healthcare around the world. The pharmaceutical market in China is expected to grow briskly as access to new medicines continues to improve. With approximately four million people diagnosed with cancer annually and 2.3 million deaths from the disease each year, the need for new oncology treatments in China is particularly acute and the oncology market is one of the fastest-growing segments of the overall pharmaceutical market there.

Amgen will purchase its equity stake in BeiGene with available cash and expects to retain its investment grade credit rating.

"Amgen’s capital allocation priorities remain unchanged," said David W. Meline, executive vice president and chief financial officer at Amgen. "We will continue to grow our business through internal investment and business development, while providing attractive returns to our shareholders through a growing dividend and continued share repurchases."

The transaction is expected to close in early 2020 subject to BeiGene shareholder approval, the expiration or termination of waiting periods under all applicable antitrust laws, and satisfaction of other customary closing conditions.

Goldman Sachs & Co. LLC is acting as exclusive financial advisor, and Latham & Watkins LLP is serving as legal advisor to Amgen.

Webcast Details
Amgen will host a webcast call today at 2 p.m. PT. where members of Amgen’s executive management team will discuss the Company’s strategic collaboration with BeiGene.  

Live audio webcast of the investor call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.  

The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.   

For more information about Amgen’s products, including important safety information, please visit www.xgeva.com, www.kyprolis.com, www.blincyto.com, www.repatha.com, and www.prolia.com.

Select Medical Holdings Corporation Announces Results For Its Third Quarter Ended September 30, 2019

On October 31, 2019 Select Medical Holdings Corporation ("Select Medical") (NYSE: SEM) reported results for its third quarter ended September 30, 2019 (Press release, Select Medical, OCT 31, 2019, View Source [SID1234550194]).

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For the third quarter ended September 30, 2019, net operating revenues increased 9.9% to $1,393.3 million, compared to $1,267.4 million for the same quarter, prior year. Income from operations increased 23.1% to $122.9 million for the third quarter ended September 30, 2019, compared to $99.8 million for the same quarter, prior year. Net income increased 3.2% to $44.0 million for the third quarter ended September 30, 2019, compared to $42.7 million for the same quarter, prior year. For the third quarter ended September 30, 2019, net income included pre-tax losses on early retirement of debt of $18.6 million. For the third quarter ended September 30, 2018, net income included a pre-tax gain on sale of businesses of $2.1 million. Adjusted EBITDA increased 16.6% to $182.7 million for the third quarter ended September 30, 2019, compared to $156.6 million for the same quarter, prior year. Earnings per common share was $0.23 on a fully diluted basis for the third quarter ended September 30, 2019, compared to $0.24 for the same quarter, prior year. Adjusted earnings per common share was $0.33 on a fully diluted basis for the third quarter ended September 30, 2019, compared to $0.23 for the same quarter, prior year. Adjusted earnings per common share excludes the losses on early retirement of debt and related costs, and their related tax effects for the third quarter ended September 30, 2019. Adjusted earnings per common share excludes the gain on sale of businesses and its related tax effects for the third quarter ended September 30, 2018. The definition of Adjusted EBITDA and a reconciliation of net income to Adjusted EBITDA are presented in table IX of this release. A reconciliation of earnings per common share to adjusted earnings per common share is presented in table X of this release.

For the nine months ended September 30, 2019, net operating revenues increased 6.9% to $4,079.3 million, compared to $3,816.6 million for the same period, prior year. Income from operations increased 9.3% to $359.5 million for the nine months ended September 30, 2019, compared to $329.0 million for the same period, prior year. Net income increased 6.9% to $157.4 million for the nine months ended September 30, 2019, compared to $147.2 million for the same period, prior year. For the nine months ended September 30, 2019, net income included pre-tax losses on early retirement of debt of $18.6 million and a pre-tax gain on sale of businesses of $6.5 million. For the nine months ended September 30, 2018, net income included pre-tax losses on early retirement of debt of $10.3 million, pre-tax gains on sales of businesses of $9.0 million, and pre-tax U.S. HealthWorks acquisition costs of $2.9 million. Adjusted EBITDA increased 8.2% to $539.0 million for the nine months ended September 30, 2019, compared to $498.1 million for the same period, prior year. Earnings per common share increased to $0.86 on a fully diluted basis for the nine months ended September 30, 2019, compared to $0.84 for the same period, prior year. Adjusted earnings per common share was $0.93 on a fully diluted basis for the nine months ended September 30, 2019, compared to $0.83 for the same period, prior year. Adjusted earnings per common share excludes the losses on early retirement of debt and related costs, gain on sale of businesses, and their related tax effects for the nine months ended September 30, 2019. Adjusted earnings per common share excludes the losses on early retirement of debt, gains on sales of businesses, U.S. HealthWorks acquisition costs, and their related tax effects for the nine months ended September 30, 2018. The definition of Adjusted EBITDA and a reconciliation of net income to Adjusted EBITDA are presented in table IX of this release. A reconciliation of income per common share to adjusted income per common share is presented in table X of this release.

Company Overview

Select Medical is one of the largest operators of critical illness recovery hospitals, rehabilitation hospitals, outpatient rehabilitation clinics, and occupational health centers in the United States based on the number of facilities. Our reportable segments include the critical illness recovery hospital segment, the rehabilitation hospital segment, the outpatient rehabilitation segment, and the Concentra segment. As of September 30, 2019, Select Medical operated 100 critical illness recovery hospitals in 28 states, 29 rehabilitation hospitals in 12 states, and 1,707 outpatient rehabilitation clinics in 37 states and the District of Columbia. Select Medical’s joint venture subsidiary Concentra operated 523 occupational health centers in 41 states. Concentra also provides contract services at employer worksites and Department of Veterans Affairs community-based outpatient clinics. At September 30, 2019, Select Medical had operations in 47 states and the District of Columbia. Information about Select Medical is available at www.selectmedical.com.

Critical Illness Recovery Hospital Segment

For the third quarter ended September 30, 2019, net operating revenues for the critical illness recovery hospital segment increased 10.2% to $462.9 million, compared to $420.1 million for the same quarter, prior year. Adjusted EBITDA for the critical illness recovery hospital segment increased 7.4% to $57.2 million for the third quarter ended September 30, 2019, compared to $53.3 million for the same quarter, prior year. The Adjusted EBITDA margin for the critical illness recovery hospital segment was 12.4% for the third quarter ended September 30, 2019, compared to 12.7% for the same quarter, prior year. Certain critical illness recovery hospital key statistics are presented in table VII of this release for both the third quarters ended September 30, 2019 and 2018.

For the nine months ended September 30, 2019, net operating revenues for the critical illness recovery hospital segment increased 4.1% to $1,381.6 million, compared to $1,327.2 million for the same period, prior year. Adjusted EBITDA for the critical illness recovery hospital segment increased 4.0% to $194.4 million for the nine months ended September 30, 2019, compared to $187.0 million for the same period, prior year. The Adjusted EBITDA margin for the critical illness recovery hospital segment was 14.1% for both the nine months ended September 30, 2019 and 2018. Certain critical illness recovery hospital key statistics are presented in table VIII of this release for both the nine months ended September 30, 2019 and 2018.

Rehabilitation Hospital Segment

For the third quarter ended September 30, 2019, net operating revenues for the rehabilitation hospital segment increased 19.9% to $173.4 million, compared to $144.6 million for the same quarter, prior year. Adjusted EBITDA for the rehabilitation hospital segment increased 45.1% to $36.8 million for the third quarter ended September 30, 2019, compared to $25.3 million for the same quarter, prior year. The Adjusted EBITDA margin for the rehabilitation hospital segment was 21.2% for the third quarter ended September 30, 2019, compared to 17.5% for the same quarter, prior year. For the third quarter ended September 30, 2018, the Adjusted EBITDA results for the rehabilitation hospital segment include start-up losses of approximately $0.8 million. Certain rehabilitation hospital key statistics are presented in table VII of this release for both the third quarters ended September 30, 2019 and 2018.

For the nine months ended September 30, 2019, net operating revenues for the rehabilitation hospital segment increased 12.9% to $488.3 million, compared to $432.7 million for the same period, prior year. Adjusted EBITDA for the rehabilitation hospital segment increased 15.2% to $92.5 million for the nine months ended September 30, 2019, compared to $80.3 million for the same period, prior year. The Adjusted EBITDA margin for the rehabilitation hospital segment was 19.0% for the nine months ended September 30, 2019, compared to 18.6% for the same period, prior year. The Adjusted EBITDA results for the rehabilitation hospital segment include start-up losses of approximately $8.8 million for the nine months ended September 30, 2019, compared to approximately $3.8 million for the same period, prior year. Certain rehabilitation hospital key statistics are presented in table VIII of this release for both the nine months ended September 30, 2019 and 2018.

Outpatient Rehabilitation Segment

For the third quarter ended September 30, 2019, net operating revenues for the outpatient rehabilitation segment increased 8.2% to $265.3 million, compared to $245.2 million for the same quarter, prior year. Adjusted EBITDA for the outpatient rehabilitation segment increased 16.0% to $40.0 million for the third quarter ended September 30, 2019, compared to $34.5 million for the same quarter, prior year. The Adjusted EBITDA margin for the outpatient rehabilitation segment was 15.1% for the third quarter ended September 30, 2019, compared to 14.1% for the same quarter, prior year. Certain outpatient rehabilitation key statistics are presented in table VII of this release for both the third quarters ended September 30, 2019 and 2018.

For the nine months ended September 30, 2019, net operating revenues for the outpatient rehabilitation segment increased 4.1% to $774.1 million, compared to $743.4 million for the same period, prior year. Adjusted EBITDA for the outpatient rehabilitation segment increased 4.3% to $111.6 million for the nine months ended September 30, 2019, compared to $107.0 million for the same period, prior year. The Adjusted EBITDA margin for the outpatient rehabilitation segment was 14.4% for both the nine months ended September 30, 2019 and 2018. Certain outpatient rehabilitation key statistics are presented in table VIII of this release for both the nine months ended September 30, 2019 and 2018.

Concentra Segment

The financial results for the Concentra segment include U.S. HealthWorks beginning February 1, 2018.

For the third quarter ended September 30, 2019, net operating revenues for the Concentra segment increased 4.3% to $421.9 million, compared to $404.5 million for the same quarter, prior year. Adjusted EBITDA for the Concentra segment increased 13.0% to $77.7 million for the third quarter ended September 30, 2019, compared to $68.8 million for the same quarter, prior year. The Adjusted EBITDA margin for the Concentra segment was 18.4% for the third quarter ended September 30, 2019, compared to 17.0% for the same quarter, prior year. Certain Concentra key statistics are presented in table VII of this release for both the third quarters ended September 30, 2019 and 2018.

For the nine months ended September 30, 2019, net operating revenues for the Concentra segment increased 5.0% to $1,231.7 million, compared to $1,173.4 million for the same period, prior year. Adjusted EBITDA for the Concentra segment increased 10.5% to $220.0 million for the nine months ended September 30, 2019, compared to $199.1 million for the same period, prior year. The Adjusted EBITDA margin for the Concentra segment was 17.9% for the nine months ended September 30, 2019, compared to 17.0% for the same period, prior year. Certain Concentra key statistics are presented in table VIII of this release for both the nine months ended September 30, 2019 and 2018.

Stock Repurchase Program

The board of directors of Select Medical has authorized a common stock repurchase program to repurchase up to $500.0 million worth of shares of its common stock. The program has been extended until December 31, 2020, and will remain in effect until then, unless further extended or earlier terminated by the board of directors. Stock repurchases under this program may be made in the open market or through privately negotiated transactions, and at times and in such amounts as Select Medical deems appropriate. Select Medical funds this program with cash on hand and borrowings under its revolving credit facility.

During the nine months ended September 30, 2019, Select Medical repurchased 2,165,221 shares at a cost of approximately $33.2 million, an average cost per share of $15.32, which includes transaction costs. Since the inception of the program through September 30, 2019, Select Medical has repurchased 38,089,349 shares at a cost of approximately $347.9 million, or $9.13 per share, which includes transaction costs.

Redemption of 6.375% Senior Notes

On August 30, 2019, Select Medical redeemed its $710.0 million 6.375% senior notes due June 1, 2021 at a redemption price of 100.000% of the principal amount, plus accrued and unpaid interest. Select Medical funded the redemption price with a portion of the net proceeds from the issuance and sale of $550.0 million 6.250% senior notes due August 15, 2026 and a portion of the proceeds from an incremental $500.0 million term loan borrowing under its senior secured credit agreement.

The redemption of the 6.375% senior notes occurred on August 30, 2019, while the issuance of the $550.0 million 6.250% senior notes occurred on August 1, 2019. As a result, Select Medical recognized interest expense on both the 6.250% senior notes and the 6.375% senior notes during August 2019.

Business Outlook

Select Medical is updating its business outlook following the reporting of its third quarter 2019 results. Select Medical now expects for the full year of 2019 consolidated net operating revenues to be in the range of $5.375 billion to $5.425 billion and Adjusted EBITDA for the full year of 2019 to be in the range of $685.0 million to $700.0 million. Select Medical now expects fully diluted earnings per common share for the full year 2019 to be in the range of $1.00 to $1.06 and adjusted earnings per common share for the full year 2019 to be in the range of $1.07 to $1.13. Adjusted earnings per common share excludes the loss on early retirement of debt and related costs, gain on sale of businesses, and their related tax effects.

Conference Call

Select Medical will host a conference call regarding its third quarter results, as well as its business outlook, on Friday, November 1, 2019, at 9:00am ET. The domestic dial in number for the call is 1-866-440-2669. The international dial in number is 1-409-220-9844. The conference ID for the call is 9264899. The conference call will be webcast simultaneously and can be accessed at Select Medical Holdings Corporation’s website www.selectmedicalholdings.com.

For those unable to participate in the conference call, a replay will be available until 12:00pm ET, November 8, 2019. The replay number is 1-855-859-2056 (domestic) or 1-404-537-3406 (international). The conference ID for the replay will be 9264899. The replay can also be accessed at Select Medical Holdings Corporation’s website, www.selectmedicalholdings.com.

Certain statements contained herein that are not descriptions of historical facts are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements due to factors including the following:

changes in government reimbursement for our services and/or new payment policies may result in a reduction in net operating revenues, an increase in costs, and a reduction in profitability;
the failure of our Medicare-certified long term care hospitals or inpatient rehabilitation facilities to maintain their Medicare certifications may cause our net operating revenues and profitability to decline;
the failure of our Medicare-certified long term care hospitals and inpatient rehabilitation facilities operated as "hospitals within hospitals" to qualify as hospitals separate from their host hospitals may cause our net operating revenues and profitability to decline;
a government investigation or assertion that we have violated applicable regulations may result in sanctions or reputational harm and increased costs;
acquisitions or joint ventures may prove difficult or unsuccessful, use significant resources or expose us to unforeseen liabilities;
our plans and expectations related to our acquisitions, including the acquisition of U.S. HealthWorks by Concentra, and our ability to realize anticipated synergies;
private third-party payors for our services may adopt payment policies that could limit our future net operating revenues and profitability;
the failure to maintain established relationships with the physicians in the areas we serve could reduce our net operating revenues and profitability;
shortages in qualified nurses, therapists, physicians, or other licensed providers could increase our operating costs significantly or limit our ability to staff our facilities;
competition may limit our ability to grow and result in a decrease in our net operating revenues and profitability;
the loss of key members of our management team could significantly disrupt our operations;
the effect of claims asserted against us could subject us to substantial uninsured liabilities;
a security breach of our or our third-party vendors’ information technology systems may subject us to potential legal and reputational harm and may result in a violation of the Health Insurance Portability and Accountability Act of 1996 or the Health Information Technology for Economic and Clinical Health Act; and
other factors discussed from time to time in our filings with the Securities and Exchange Commission (the "SEC"), including factors discussed under the heading "Risk Factors" of the quarterly reports on Form 10-Q and of the annual report on Form 10-K for the year ended December 31, 2018.

Intellia Therapeutics Announces Third Quarter 2019 Financial Results

On October 31, 2019 Intellia Therapeutics, Inc. (NASDAQ:NTLA), reported operational highlights and financial results for the third quarter ended September 30, 2019 (Press release, Intellia Therapeutics, OCT 31, 2019, View Source [SID1234550101]).

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"In 2019, we continued to leverage the breadth of our genome editing platform to advance our in vivo and engineered cell therapy programs. We have demonstrated that we can knock out a disease-causing gene as well as introduce a functional gene to restore normal protein production. Now, we have achieved consecutive editing in vivo by combining both these edit types, further highlighting the versatility of our modular platform," said Intellia President and Chief Executive Officer, John Leonard, M.D. "Our full-spectrum strategy and platform capabilities are enabling Intellia’s development of a robust pipeline to address a range of severe diseases. We look forward to the planned nomination of our first engineered cell therapy development candidate for acute myeloid leukemia by year-end and the submission of our first IND application for NTLA-2001 for the treatment of transthyretin amyloidosis in mid-2020."

Third Quarter 2019 and More Recent Operational Highlights

ATTR Program: Intellia remains on track to submit in mid-2020 an investigational new drug (IND) application for NTLA-2001 for the treatment of transthyretin amyloidosis (ATTR). NTLA-2001 is anticipated to be the first systemically delivered CRISPR/Cas9 therapy to enter the clinic. As part of an ongoing durability study of its lead lipid nanoparticle (LNP) formulation in support of NTLA-2001, Intellia has demonstrated 10 months of durable liver editing with sustained reduction of circulating transthyretin (TTR) protein (average reduction >95%) following a single dose in non-human primates. In preparation for the submission of the IND application, the Company announced today it has commenced clinical-scale manufacturing for Phase 1 materials. NTLA-2001 is part of a co-development/co-promotion (Co/Co) agreement with Regeneron Pharmaceuticals, Inc., with Intellia as the lead development and commercialization party.
WT1-TCR for AML Program: Intellia is on track to nominate its first T cell receptor (TCR)-directed engineered cell therapy development candidate by the end of 2019. The initial application of the in-locus TCR-based approach consists of autologous T cells directed towards the intracellular antigen Wilms’ Tumor 1 (WT1) for the treatment of acute myeloid leukemia (AML). During the third quarter and more recently, Intellia continued to generate data from ongoing studies of multiple lead TCRs in patient-derived xenograft models to support the nomination of a development candidate for AML. Concurrently, the Company advanced GMP manufacturing-related development activities in support of a Phase 1 clinical trial.
In Vivo Platform: At the recent 2019 European Society of Gene and Cell Therapy (ESGCT) Annual Meeting, Intellia presented the first demonstration of consecutive in vivo gene knockout and targeted insertion in an alpha-1 antitrypsin deficiency (AATD) mouse model. The consecutive edits led to >98% reduction of the disease-causing protein and sustained restoration of the normal protein to therapeutically relevant circulating levels throughout the study.The novel genome editing strategy is enabled by the ability to sequentially dose with LNPs, one of the key advantages to Intellia’s non-viral delivery system.
Upcoming Milestones

The Company has set forth the following for pipeline progression:

ATTR:
Submit IND application for NTLA-2001 in mid-2020

AML:
Nominate first engineered cell therapy development candidate by the end of 2019
Upcoming Events

The Company will participate in the following investor events:

Credit Suisse Healthcare Conference, November 12, Scottsdale, Arizona
Barclays Gene Editing and Gene Therapy Summit, November 13, New York City
Third Quarter 2019 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $295.8 million as of September 30, 2019, compared to $314.1 million as of December 31, 2018. The decrease was driven by cash used to fund operations of approximately $90.5 million, which was offset in part by $54.1 million of net equity proceeds raised from the Company’s "At the Market" (ATM) agreement, $8.0 million of funding received under the Novartis collaboration, $7.3 million of ATTR cost reimbursements made by Regeneron, and $2.8 million in proceeds from employee-based stock plans.
Collaboration Revenue: Collaboration revenue increased by approximately $3.2 million to $10.6 million during the third quarter of 2019, compared to $7.4 million during the third quarter of 2018. The increase in collaboration revenue in 2019 was primarily driven by amounts recognized from the expansion of the existing collaboration with Novartis, as well as by amounts recognized under the Company’s ATTR Co/Co agreement with Regeneron. As previously disclosed, Regeneron funds approximately 50% of the development costs for the ATTR program.
R&D Expenses: Research and development expenses increased by approximately $4.3 million to $27.5 million during the third quarter of 2019, compared to $23.2 million during the third quarter of 2018. This increase was driven primarily by the advancement of Intellia’s research programs, research personnel growth to support these programs, as well as the expansion of the development organization.
G&A Expenses: General and administrative expenses increased by approximately $0.2 million to $8.4 million during the third quarter of 2019, compared to $8.3 million during the third quarter of 2018. This increase was driven primarily by employee-related expenses to support Intellia’s growing research and development efforts.
Net Loss: The Company’s net loss was $23.6 million for the third quarter of 2019, compared to $22.7 million during the third quarter of 2018.
Financial Guidance

Intellia expects that its cash, cash equivalents and marketable securities as of September 30, 2019, as well as technology access and funding from Novartis and Regeneron, will enable Intellia to fund its anticipated operating expenses and capital expenditure requirements into the second half of 2021. This expectation excludes any potential milestone payments or extension fees that could be earned and distributed under the collaboration agreements with Novartis and Regeneron or any strategic use of capital not currently in the Company’s base-case planning assumptions.

Conference Call to Discuss Third Quarter 2019 Earnings

The Company will discuss these results on a conference call today, October 31, 2019, at 8 a.m. ET.

To join the call:

U.S. callers should dial 888-208-1711 and use conference ID# 7693636, approximately five minutes before the call.
International callers should dial + 1 856-344-9299 and use conference ID# 7693636, approximately five minutes before the call.
A replay of the call will be available through the Events and Presentations page of the Investor Relations section on Intellia’s website, beginning on October 31, 2019 at 12 p.m. ET.