On November 8, 2018 FibroGen, Inc. (NASDAQ: FGEN), a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics, reported financial results for the third quarter of 2018 and provided an update on the company’s recent developments (Press release, FibroGen, NOV 8, 2018, View Source;p=irol-newsArticle&ID=2376324 [SID1234531045]).

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"With new drug applications for roxadustat in anemia associated with chronic kidney disease supported by positive Phase 3 results and under review in China and Japan, we look forward to the upcoming reporting of topline clinical results, pooled safety data and submitting our U.S. NDA," said Thomas B. Neff, FibroGen’s Chief Executive Officer. "For pamrevlumab, our proprietary anti-fibrotic and anti-fibroproliferative therapeutic candidate, we are initiating Phase 3 studies in idiopathic pulmonary fibrosis, and in unresectable locally advanced pancreatic cancer, in the first quarter of 2019."

Recent Developments and Highlights
Roxadustat for Anemia in Chronic Kidney Disease (CKD) in the U.S./EU

Topline Phase 3 clinical results anticipated for the fourth quarter of this year
Pooled MACE analysis results and submission of New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) anticipated in the first half of 2019
Astellas reported positive topline efficacy and safety results from the first global trial, ALPS, a Phase 3 placebo-controlled study evaluating roxadustat in non-dialysis-dependent CKD anemia patients in September 2018
Astellas also completed its global trial, PYRENEES, a Phase 3 study in dialysis patients
Roxadustat for Anemia in CKD in China

Roxadustat NDA approval for the treatment of dialysis-dependent CKD is anticipated by year-end 2018, followed by approval in CKD non dialysis
Clinical results from two Phase 3 studies conducted in China were presented at the American Society of Nephrology (ASN) Kidney Week 2018 annual meeting in October
Roxadustat for Anemia in CKD in Japan

Astellas NDA for roxadustat was filed with the Pharmaceuticals and Medical Devices Agency (PMDA) for anemia associated with dialysis-dependent CKD, triggering a $15 million milestone payment to FibroGen
Astellas announced positive topline results from the four Phase 3 dialysis-dependent studies that support the Japan NDA
Clinical results from two of the four Japan Phase 3 trials in dialysis-dependent patients were presented at the ASN Kidney Week 2018:
A Phase 3 trial in peritoneal dialysis patients was presented in an oral session
A Phase 3 darbepoetin alfa controlled study in stable hemodialysis patients previously treated with ESA was presented in a clinical late-breaking poster session
One of two non-dialysis-dependent Phase 3 studies supporting approval for non-dialysis is now completed
Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)

Clinical and preclinical data presented at the European Respiratory Society International Congress (ERS) 2018 and 20th International Colloquium on Lung and Airway Fibrosis (ICLAF) 2018
Fast Track designation received from the FDA
Plan to start a randomized, double-blind, placebo-controlled Phase 3 clinical trial with a primary endpoint of change in forced vital capacity (FVC) from baseline in approximately 500 patients, in the first quarter of 2019
Pamrevlumab for Pancreatic Cancer

On track to start a randomized, double-blind, placebo-controlled Phase 3 study evaluating pamrevlumab in combination with gemcitabine and nab-paclitaxel as a neoadjuvant therapy for unresectable locally advanced pancreatic cancer (LAPC) in approximately 260 patients in the first quarter of 2019
Corporate and Financial

Net loss for the third quarter was $42.6 million, or ($0.50) per share, compared to $24.5 million, or ($0.32) per share, for the same period in 2017
At September 30, 2018, FibroGen had $722.6 million of cash, cash equivalents, investments, restricted time deposits, and receivables
The weighted average number of common shares used to calculate net loss per share was 84.5 million shares and 75.9 million shares for the third quarters of 2018 and 2017, respectively.
Total shares outstanding as of September 30, 2018 were 84.8 million shares
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Thursday, November, 8, 2018, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (888) 771-4371 (U.S. and Canada) or 1 (847) 585-4405 (international), reference the FibroGen third quarter 2018 financial results conference call, and use passcode 47780296. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial 1 (888) 843-7419 (domestic) or 1 (630) 652-3042 (international), and use passcode 4778 0296#.

About Roxadustat
Roxadustat (FG-4592) is a first-in-class, orally administered small molecule currently in global Phase 3 clinical development as a potential therapy for anemia associated with chronic kidney disease (CKD). Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that promotes erythropoiesis through increasing endogenous erythropoietin, improving iron regulation, and reducing hepcidin. Administration of roxadustat has been shown to induce coordinated erythropoiesis – increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of CKD patients, including in the presence of inflammation and without a need for supplemental intravenous iron.

FibroGen and collaboration partners are pursuing four approval pathways in major jurisdictions to prepare for commercialization worldwide:

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa.
AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in the U.S., China, and other markets in the Americas and in Australia/New Zealand as well as Southeast Asia.
FibroGen and its partners have completed 35 Phase 1 and Phase 2 studies. The Phase 2 clinical studies have consistently demonstrated anemia correction and maintenance of hemoglobin levels in multiple subpopulations across a wide spectrum of CKD patients.

Globally, the Phase 3 program encompasses a total of 15 Phase 3 studies of roxadustat in both non-dialysis-dependent and dialysis-dependent CKD patients to support independent regulatory approvals in the U.S., Europe, Japan, and China. To date, positive topline results have been announced for seven of the Phase 3 studies, with two supporting the China NDA for treatment of anemia in CKD patients on dialysis and not on dialysis, four supporting the Japan NDA for treatment of anemia in CKD patients on dialysis, and one supporting the U.S./EU submissions. The China and Japan NDAs are both under review by the respective regulatory agencies.

Roxadustat is currently in Phase 3 clinical development for the treatment of anemia associated with myelodysplastic syndromes (MDS) in the U.S. and in Phase 2/3 development for MDS in China.

About Pamrevlumab
Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab is advancing towards Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, has been granted Orphan Drug Designation (ODD) in each of these indications, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). Pamrevlumab has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of patients with locally advanced unresectable pancreatic cancer. Across all trials, pamrevlumab has consistently demonstrated a good safety and tolerability profile to date. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

On November 8, 2018 Apollo Endosurgery, Inc. ("Apollo") (Nasdaq: APEN), a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, reported financial results for the third quarter ended September 30, 2018 (Press release, Lpath, NOV 8, 2018, View Source [SID1234531161]).

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Third Quarter 2018 Highlights
• ESS contributed 37% of total sales in the quarter
• U.S. ESS sales increased 24% year-over-year in the quarter and 34% in the first nine months of 2018
• Worldwide ESS sales increased 40% in the first nine months of 2018
• Completed two gross margin improvement projects projected to contribute $2 million annually starting in 2019
Todd Newton, CEO of Apollo, commented, "ESS sales contributed 37% of overall revenue in the third quarter, showing solid progress despite a challenging comparable period in certain OUS markets in the prior year. We also achieved good IGB sales growth in the markets where Orbera365, our 12-month product is available. And finally, we are pleased to announce the completion of our two gross margin improvement projects that will add an estimated $2 million annually to our Endo gross margin beginning in 2019."
Third Quarter 2018 Results
Total revenues in the third quarter of 2018 were $14.1 million, compared to $16.5 million in the third quarter 2017, a decrease of 15%. Foreign currency fluctuations decreased total revenues $0.3 million for the three months ended September 30, 2018.
U.S. Endoscopic Suturing System ("ESS") product sales increased 24% to $2.5 million due to continuing new user adoption and greater product utilization in existing accounts. Outside the U.S. ("OUS") ESS product sales decreased 6%, to $2.7 million, due to lower third quarter 2018 sales in Australia and Brazil. Brazil ESS sales, in the third quarter of the prior year, included large initial orders with the launch of OverStitch in that country following regulatory approval in July 2017. In Australia, the third quarter of the prior year experienced elevated levels of ESS sales as providers used a gastroplasty code for ESG reimbursement before the Australian government warned against use of this code for obesity-related treatments at the end of 2017. These circumstances offset continued ESS growth during the third quarter in remaining OUS markets. In total, ESS product sales increased 6% to $5.2 million in the third quarter 2018 compared to $4.9 million in the third quarter 2017.
Total Intragastric balloon ("IGB") product sales decreased 8% to $4.1 million in the third quarter 2018 compared to $4.4 million in the third quarter 2017. OUS IGB product sales decreased 8%, to $2.9 million as higher unit sales and average selling prices of Orbera365 in Europe were offset by weaker six-month balloon sales in Brazil. In the U.S., IGB product sales decreased $0.1 million, or 7% to $1.2 million due to decreased consumer demand following the June 2018 FDA letter to Health Care Professionals ("HCPs").
Total Surgical product sales decreased $2.4 million, or 34% in the third quarter 2018 compared to the third quarter 2017 due to reductions in gastric banding procedures being performed worldwide.
Gross margin for the third quarter 2018 was 55%, compared to 64% for the third quarter 2017, resulting from a greater proportion of our overall product sales coming from our ESS products, which realize a lower gross margin than our other products. We have now completed two additional gross margin improvement projects related to the cinch component of OverStitch and the IGB delivery system, which on a combined basis will improve gross margin by approximately $2 million annually beginning in 2019.
Total operating expenses increased $1.0 million to $15.8 million in the third quarter 2018, compared to the third quarter 2017. The increase was due to higher research and development expenses in the third quarter primarily attributable to clinical study activities associated with our Endobariatric products, new product development activities, and margin improvement project activities.
Net loss for the third quarter 2018 was $9.8 million compared to $4.9 million for the third quarter 2017. The increased net loss was primarily due to lower gross profit and higher research and development expenses.

Cash, cash equivalents and restricted cash were $29.5 million as of September 30, 2018, which includes principal payments of $2.5 million on our credit facility during the quarter.
Conference Call
Apollo will host a conference call on November 8, 2018 at 3:30 p.m. Central Time / 4:30 p.m. Eastern Time to discuss Apollo’s operating results for the third quarter ended September 30, 2018.
To participate in the conference call dial (866) 393-4306 for domestic callers and (734) 385-2616 for international callers. The conference ID number is 3448713. A live webcast of the conference call will be made available on the "Events and Presentations" section of our Investor Relations website: www.ir.apolloendo.com.
A replay of the webcast will be made available on Apollo’s website, www.apolloendo.com following the event.

On November 7, 2018 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development and commercialization of innovative therapeutics for the treatment of cancer, reported upcoming presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting and participation in an analyst-moderated Q&A panel at Cowen’s 2nd Annual IO NEXT Summit (Press release, Curis, NOV 7, 2018, View Source [SID1234530914]). Curis’ poster presentations will take place on Friday, Nov. 9, with a poster from collaborator Aurigene on Saturday, Nov. 10, at Hall E of the Walter E. Washington Convention Center in Washington, D.C. The Cowen 2nd Annual IO NEXT Summit will take place at the Marriott Marquis in Washington, D.C. featuring a discussion with Jim Dentzer, President and CEO, and Dr. Robert Martell, Head of Research and Development, in an analyst-hosted fireside chat.

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In three posters at the SITC (Free SITC Whitepaper) conference, Curis will present evidence supporting the presence of high VISTA expression on tumor cells, preclinical data supporting VISTA’s ability to independently suppress T cell responses, and Phase 1 clinical trial data of CA-170 in patients with advanced tumors and lymphomas. In addition, Curis collaborator Aurigene will present a poster detailing key findings from its ongoing Phase 2 trial of CA-170 in patients with advanced solid tumors and Hodgkin lymphoma who are immunotherapy treatment-naïve.

Details of these presentations are as follows:

Cowen IO NEXT Summit

Date/Time:

Friday, Nov. 09, 11:50 AM – 12:10 PM EST

Presenters:

Jim Dentzer, President and Chief Executive Officer

Robert Martell, M.D., Ph.D., Head of Research and Development

Location:

Marriot Marquis Washington, DC

Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting

CA-170 Poster Presentations from Curis:

Date/Time:

Friday, Nov. 9, 12:45 PM – 2:15 PM, 6:30 PM – 8:00 PM EST

Location:

Hall E, Walter E. Washington Convention Center

Abstract Number:

P135

Presentation Title:

Integrative genomic and proteomic analysis identifies cancer subtypes and signaling networks associated with aberrant tumor expression of VISTA

Abstract Number:

P139

Presentation Title:

Pharmacodynamic effects of CA-170, a first-in-class small molecule oral immune checkpoint inhibitor (ICI) dually targeting V-domain Ig suppressor of T-cell activation (VISTA) and PDL1

Abstract Number:

P341

Presentation Title:

Phase 1 study of CA-170, a first-in-class, orally available, small molecule immune checkpoint inhibitor (ICI) dually targeting VISTA and PDL1, in patients with advanced solid tumors or lymphomas

CA-170 Poster Presentation from Aurigene:

Date/Time:

Saturday, Nov. 10, 12:20 PM – 1:50 PM, 7:00 PM – 8:30 PM EST

Location:

Hall E, Walter E. Washington Convention Center

Abstract Number:

P714

Presentation Title:

Phase 2 trial of CA-170, a novel oral small molecule dual inhibitor of immune checkpoints VISTA and PD-1, in patients with advanced solid tumor and Hodgkin lymphoma

On November 7, 2018 Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, reported its consolidated financial results for the third quarter 2018 and reviewed recent commercial and R&D highlights (Press release, Alnylam, NOV 7, 2018, View Source [SID1234530997]).

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"The third quarter and recent period were truly revolutionary for Alnylam with the approval of ONPATTRO in both the U.S. and EU, heralding the arrival of RNAi therapeutics as a whole new class of medicines. With these approvals and the subsequent launches, we have begun to realize the promise of RNAi therapeutics on a global scale," said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. "Our recent regulatory and commercial launch experiences will be leveraged for our entire portfolio including late-stage programs such as givosiran, where we will initiate a rolling NDA submission this year; lumasiran, which we have advanced into late-stage development with the recent initiation of the ILLUMINATE-A Phase 3 study; and ALN-TTRsc02, which will enter Phase 3 later this year in the HELIOS-A study. We believe these accomplishments put us well on our way toward achieving our Alnylam 2020 goal of building a multi-product, global, commercial-stage company with a deep and sustainable clinical pipeline by the end of 2020."

"With the approval and launch of ONPATTRO, Alnylam is now a global commercial-stage company. With only seven weeks of results for the third quarter, we’re encouraged by the number of U.S. patient start forms, and emerging prescriber base, highlighting what we believe is strong demand for ONPATTRO for adults with polyneuropathy caused by hATTR amyloidosis. Moreover, we believe our regional presence in North America, Europe, Asia, and, soon, Latin America, along with established medical affairs and supply chain capabilities, positions us to expand our efforts in markets around the world," said Barry Greene, President of Alnylam. "We look forward to continuing our work toward strong commercial execution, with a focus on raising disease awareness, improving diagnosis, and bringing ONPATTRO to patients in need."

Third Quarter 2018 and Recent Period Significant Corporate Highlights

Commercial Highlights

Launched ONPATTRO (patisiran) in the U.S. and EU, initially in Germany.
Received 125 U.S. patient Start Forms as of September 30, 2018.
Recognized ONPATTRO revenue of $0.5 million for the quarter ended September 30, 2018.
Announced alignment on value-based agreements with leading health insurers and launched Alnylam Assist, a comprehensive patient support services program for ONPATTRO in the U.S.
R&D Highlights

Achieved the first-ever regulatory approval of an RNAi therapeutic, ONPATTRO (patisiran), in the U.S. and EU.
Received U.S. Food and Drug Administration (FDA) approval of ONPATTRO for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.
Received marketing authorization from the European Commission for ONPATTRO for the treatment of hATTR amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy.
Continued global efforts to bring ONPATTRO to patients with submission of a New Drug Application to Japan’s Pharmaceuticals and Medical Devices Agency and receipt of a Priority Review designation in Canada.
Published results from the APOLLO Phase 3 study of patisiran in the July 5, 2018 issue of The New England Journal of Medicine and APOLLO exploratory cardiac endpoint data in the September 14, 2018 issue of Circulation.
Advanced ALN-TTRsc02, a subcutaneously administered investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis.
Aligned the design of HELIOS-A, a pivotal Phase 3 study of ALN-TTRsc02 in patients with hATTR amyloidosis polyneuropathy, with FDA and European Medicines Agency (EMA) feedback.
The Company is on track to start the HELIOS-A study in late 2018 and plans to initiate additional Phase 3 studies of ALN-TTRsc02, including in hereditary and wild-type ATTR amyloidosis cardiomyopathy, in 2019.
Advanced givosiran, an investigational RNAi therapeutic in development for the treatment of acute hepatic porphyrias (AHPs).
Announced positive topline results from the interim analysis of the ENVISION Phase 3 study of givosiran.
Announced plans to initiate a rolling submission of a New Drug Application (NDA) and pursue full approval based on complete results – now expected in early 2019 – from the ENVISION Phase 3 study. The rolling NDA submission is expected to be initiated in 2018, with full clinical sections submitted in mid-2019, assuming positive results.
Advanced lumasiran, an investigational RNAi therapeutic in development for the treatment of primary hyperoxaluria type 1 (PH1).
Announced initiation of ILLUMINATE-A, a global Phase 3 pivotal trial of lumasiran in children and adults with PH1. Alnylam expects to report topline results from ILLUMINATE-A in late 2019 and, if positive, submit filings for global regulatory approvals starting in early 2020.
Presented updated positive results from the Phase 1/2 study in PH1 patients at the 2018 European Society for Paediatric Nephrology and the American Society of Nephrology annual meetings.
Announced alignment with the FDA on the trial design for ILLUMINATE-B, a Phase 3 study of lumasiran in PH1 patients less than six years of age with preserved renal function.
Expanded the Alnylam Act program to include no-charge, third-party genetic testing and counseling for adults and children who may carry a mutation in the gene encoding alanine-glyoxylate aminotransferase (AGXT), which is associated with PH1.
Alnylam’s partner, The Medicines Company, announced in October that the Independent Data Monitoring Committee for the ongoing inclisiran Phase 3 clinical trials (ORION 9, 10, and 11) conducted its fourth planned review of safety and efficacy data from the ORION trials and recommended that the trials continue without modification.
The safety database for inclisiran now provides 1,899 years of patient exposure to an RNAi therapeutic, representing the industry’s most comprehensive body of safety data for an RNAi therapeutic.
Alnylam’s partner, Sanofi, continues enrollment in the fitusiran Phase 3 ATLAS program in patients with hemophilia A or B with and without inhibitors.
Advanced early-stage RNAi pipeline.
Submitted a Clinical Trial Authorization (CTA) application for ALN-AAT02, an investigational RNAi therapeutic for the treatment of alpha-1 antitrypsin deficiency-associated liver disease (alpha-1 liver disease), which is based on Alnylam’s Enhanced Stabilization Chemistry-Plus (ESC+) GalNAc conjugate technology.
The Company announces today that due to recruitment challenges, it has discontinued a Phase 2 study of cemdisiran in atypical hemolytic uremic syndrome (aHUS). Alnylam will now focus its cemdisiran clinical efforts on a Phase 2 study in IgA nephropathy.
Reported new platform innovations at the Oligonucleotide Therapeutics Society 2018 Annual Meeting, including pre-clinical results demonstrating CNS and ocular delivery of RNAi therapeutics in rats and non-human primates.
Additional Business Updates

Expanded organization with key appointments and new hires.
Appointed Dr. Margaret Hamburg, former FDA Commissioner, to the Board of Directors, effective January 10, 2019. Concurrent with Dr. Hamburg’s appointment, Mr. John Clarke is resigning from the Board after sixteen years of service.
Alnylam announces today the promotion of Andy Orth as Senior Vice President, Head of U.S. In this role, he is responsible for commercial execution of Alnylam programs in the U.S. market. He was previously Alnylam’s Vice President of Commercial Operations, and joined the Company in 2016 from Biogen. Prior to Biogen, he held commercial and finance leadership roles at Genzyme and Amgen.
Alnylam also announces today the appointment of Norton Oliveira as Senior Vice President, Head of Latin America. He joins Alnylam from Gilead Sciences where he was Vice President for Latin America and the Caribbean. Prior to Gilead, Norton held commercial leadership roles at Merck/MSD and Shire.
Upcoming Events

In late 2018, Alnylam intends to:

Initiate a rolling submission of an NDA with the FDA for givosiran, with full clinical sections to be submitted in mid-2019, assuming positive results.
Initiate the HELIOS-A Phase 3 study for ALN-TTRsc02 in hATTR amyloidosis.
Initiate the Phase 1/2 study for ALN-AAT02 in alpha-1 liver disease.
File a Clinical Trial Authorization (CTA) application for ALN-HBV02 (also known as VIR-2218), in partnership with Vir Biotechnology, for the treatment of chronic hepatitis B virus infection.
Select its first CNS-targeted development candidate (DC) program.
Hold an R&D Day Investor Conference on December 6 in New York City.
Financial results for the quarter ended September 30, 2018

"We are pleased to have recognized initial revenue for an Alnylam product for the first time in the Company’s history, following the August FDA approval of ONPATTRO," said Manmeet Soni, Chief Financial Officer of Alnylam. "With cash and investments on our balance sheet standing at $1.27 billion at September 30, and expectations to finish the year with approximately $1.0 billion, we believe Alnylam is in a strong position to continue executing on global commercial operations while advancing our pipeline programs through the clinic."

Cash and Investments
At September 30, 2018, Alnylam had cash, cash equivalents and marketable debt securities, and restricted investments, excluding equity securities, of $1.27 billion, as compared to $1.73 billion at December 31, 2017.

GAAP and Non-GAAP Net Loss
The net loss according to accounting principles generally accepted in the U.S. (GAAP) for the third quarter of 2018 was $245.3 million, or $2.43 per share on both a basic and diluted basis, as compared to a net loss of $122.9 million, or $1.34 per share on both a basic and diluted basis, for the same period in the previous year.

The non-GAAP net loss for the third quarter of 2018 was $157.3 million, or $1.56 per share on both a basic and diluted basis, as compared to a non-GAAP net loss of $97.0 million, or $1.06 per share on both a basic and diluted basis, for the same period in the previous year.

The non-GAAP net loss for the third quarter of 2018 and 2017 excludes stock-based compensation expense. See "Use of Non-GAAP Financial Measures" below for a description of non-GAAP financial measures and a reconciliation between GAAP and non-GAAP net loss appearing later in this press release.

ONPATTRO Revenues, Net
Net product revenues from sales of ONPATTRO were $0.5 million in the third quarter of 2018 following its approval by the FDA in August 2018.

Net Revenues from Collaborators
Net revenues from collaborators were $1.6 million in the third quarter of 2018 as compared to $17.1 million in the third quarter of 2017.

GAAP and Non-GAAP Research and Development Expenses
GAAP research and development (R&D) expenses were $139.9 million in the third quarter of 2018 as compared to $95.3 million in the third quarter of 2017.

Non-GAAP R&D expenses were $94.2 million in the third quarter of 2018 as compared to $80.2 million in the third quarter of 2017. Non-GAAP R&D expenses exclude stock-based compensation expense. A reconciliation between GAAP and non-GAAP R&D expenses appears later in this press release.

GAAP and Non-GAAP Selling, General and Administrative Expenses
GAAP selling, general and administrative (SG&A) expenses were $116.5 million in the third quarter of 2018 as compared to $47.6 million in the third quarter of 2017.

Non-GAAP SG&A expenses were $74.4 million in the third quarter of 2018 as compared to $36.8 million in the third quarter of 2017. Non-GAAP SG&A expenses exclude stock-based compensation expense. A reconciliation between GAAP and non-GAAP SG&A expenses appears later in this press release.

2018 Financial Guidance
Alnylam reiterates its expectations to end 2018 with approximately $1.0 billion of cash, cash equivalents and marketable debt securities, restricted cash and restricted investments, excluding equity securities.

The Company reiterates its expectations for 2018 annual non-GAAP R&D expenses to be in the range of $420 million to $460 million and non-GAAP SG&A expenses to be in the range of $280 million to $320 million. Both non-GAAP R&D and non-GAAP SG&A expenses exclude stock-based compensation expenses.

Use of Non-GAAP Financial Measures
This press release contains non-GAAP financial measures, including expenses adjusted to exclude certain non-cash expenses and non-recurring gains outside the ordinary course of the Company’s business. These measures are not in accordance with, or an alternative to, GAAP, and may be different from non-GAAP financial measures used by other companies.

The items included in GAAP presentations but excluded for purposes of determining non-GAAP financial measures for the periods presented in the press release are stock-based compensation expense and the gain on litigation settlement. The Company has excluded the impact of stock-based compensation expense, which may fluctuate from period to period based on factors including the variability associated with performance-based grants for stock options and restricted stock units and changes in the Company’s stock price, which impacts the fair value of these awards. The Company has excluded the impact of the gain on litigation settlement because the Company believes this item is a one-time event occurring outside the ordinary course of the Company’s business.

The Company believes the presentation of non-GAAP financial measures provides useful information to management and investors regarding the Company’s financial condition and results of operations. When GAAP financial measures are viewed in conjunction with non-GAAP financial measures, investors are provided with a more meaningful understanding of the Company’s ongoing operating performance and are better able to compare the Company’s performance between periods. In addition, these non-GAAP financial measures are among those indicators the Company uses as a basis for evaluating performance, allocating resources and planning and forecasting future periods. Non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between GAAP and non-GAAP measures is provided later in this press release.

Conference Call Information
Management will provide an update on the Company and discuss third quarter 2018 and recent period results as well as expectations for the future via conference call on Wednesday, November 7, 2018 at 8:30 am ET. To access the call, please dial 800-667-5617 (domestic) or 334-323-0509 (international) five minutes prior to the start time and refer to conference ID 7650424. A replay of the call will be available beginning at 11:30 am ET on the day of the call. To access the replay, please dial 888-203-1112 (domestic) or 719-457-0820 (international) and refer to conference ID 7650424.

On November 7, 2018 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, reported that President and Chief Executive Officer Guy Macdonald will present a corporate overview at the Stifel 2018 Healthcare Conference on Wednesday, November 14, 2018 at 8:00 a.m. ET at Lotte New York Palace Hotel in New York City. Mr. Macdonald also will participate in a fireside chat at the Piper Jaffray 30th Annual Healthcare Conference on Tuesday, November 27, 2018 at 2:30 p.m. ET at the Lotte New York Palace Hotel in New York City.

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A live audio webcast of the Stifel 2018 Healthcare Conference presentation will be available on the Company’s website at View Source The archived presentation will be available for 30 days.