On November 1, 2018 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to probiotics to develop novel, living medicines, reported that the Company will host an event for analysts and investors in conjunction with the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 33rd Annual Meeting * Pre-Conference Programs (SITC 2018), with formal presentations beginning at 12:30 pm ET on November 10, 2018 (Press release, Synlogic, NOV 1, 2018, View Source [SID1234530624]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

At SITC (Free SITC Whitepaper) 2018, Synlogic will deliver a poster presentation of preclinical data for its innate immune activator candidate. Details about the poster presentation and abstract are below:

Title: Development of a STING Agonist-producing Synthetic Biotic Medicine to Activate Innate and Adaptive Immunity and Drive Antitumor Immune Responses
Abstract ID: P624
Location: Poster Hall Location: Hall E
Time:Friday, Nov. 9 from 8:00 am– 8:00 pm ET and Saturday, Nov. 10 from 8:00 am – 8:30 pm ET
The analyst and investor event will expand on these data to highlight the potential of Synlogic’s Synthetic Biotic platform in immuno-oncology, with featured speakers including:

Synlogic management
Filip Janku, MD, PhD; MD Anderson Cancer Center
Dmitriy Zamarin, MD, PhD; Memorial Sloan Kettering Cancer Center
A live webcast of the presentation and accompanying slides will be available under "Events and Presentations" in the News & Investors section of the Company’s website at www.synlogictx.com. An archived webcast recording of the event will be available on the website for approximately 30 days.

On November 1, 2018 Corcept Therapeutics Incorporated (NASDAQ: CORT), a company engaged in the discovery, development and commercialization of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, reported its results for the quarter ended September 30, 2018 (Press release, Corcept Therapeutics, NOV 1, 2018, View Source [SID1234530622]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Financial Highlights

Revenue of $64.4 million, a 51 percent increase from third quarter 2017
GAAP net income of $0.14 per share, compared to $0.11 per share in third quarter 2017
Non-GAAP net income of $0.22 per share, compared to $0.14 per share in third quarter 2017
Cash and investments of $196.7 million, a $36.8 million increase from second quarter 2018
Reaffirmed 2018 revenue guidance of $250-270 million
Corcept reported revenue of $64.4 million for the third quarter, compared to $42.8 million in the same period last year. GAAP net income was $17.7 million, compared to $13.8 million in the third quarter of 2017. Excluding non-cash expenses related to stock-based compensation, use of deferred tax assets, interest on the company’s retired royalty financing obligation and related income tax effects, non-GAAP net income in the third quarter was $27.9 million, compared to $17.4 million in the third quarter of 2017. A reconciliation of GAAP to non-GAAP net income is set forth below.

Operating expenses for the third quarter were $41.5 million, compared to $29.1 million in the third quarter of 2017, primarily due to increased spending to advance relacorilant, CORT118335 and CORT125281 and costs arising from increased sales volume.

Cash and investments were $196.7 million at September 30, 2018, compared to $159.9 million at June 30, 2018. The company spent $8.9 million in the third quarter repurchasing 674,000 shares of its common stock. Under the terms of Corcept’s stock repurchase program as currently authorized, $91.1 million remains available for the repurchase of shares.

Relacorilant to Treat Patients with Cushing’s Syndrome

Enrollment open in relacorilant’s 130-patient Phase 3 trial
Relacorilant designated orphan drug for treatment of Cushing’s syndrome
The Phase 3 trial of Corcept’s proprietary, selective cortisol modulator, relacorilant, is expected to enroll 130 patients at sites in the United States and Europe. In the trial’s initial, open-label phase, patients will receive relacorilant for 22 weeks. Any patients who exhibit clinically meaningful improvements in hypertension or glucose tolerance will then enter a twelve-week, double-blind, placebo-controlled "withdrawal phase," during which half will continue to receive relacorilant and the rest, placebo. The rate and degree of relapse in patients receiving placebo will be measured against the rate and degree of relapse in those continuing relacorilant.

For more information about the trial, go to clinicaltrials.gov.

Because the FDA has designated relacorilant as an orphan drug for the treatment of Cushing’s syndrome, Corcept will receive tax credits for clinical trial costs, marketing application filing fee waivers if the drug is approved, as well as assistance from the FDA in the drug development process. Patents covering relacorilant’s composition of matter and use to treat Cushing’s syndrome expire in 2033.

"We’re excited to have started relacorilant’s Phase 3 trial," said Joseph K. Belanoff, MD. "Our Cushing’s syndrome franchise continues to add new prescribers of our first-generation cortisol modulator, Korlym, in every region of the country, and we expect it will continue to do so. Relacorilant promises to make the benefits of cortisol modulation even more widely available. Patients in relacorilant’s Phase 2 trial experienced significant clinical benefit, but not Korlym’s serious off-target effects – endometrial thickening, vaginal bleeding and hypokalemia. If these safety and efficacy results are confirmed in Phase 3, relacorilant will constitute a major clinical and commercial advance."

Oncologic & Metabolic Disorders

Selective cortisol modulator CORT118335 safe and well-tolerated in Phase 1; Phase 2 trials in antipsychotic-induced weight gain and non-alcoholic steatohepatitis (NASH) planned to start in first quarter 2019
Further results expected by year-end in Phase 1/2 trial of relacorilant plus Abraxane (nab-paclitaxel) to treat metastatic pancreatic cancer; FDA grants relacorilant orphan drug status for that indication
Controlled Phase 2 trial of relacorilant plus Abraxane to treat metastatic ovarian cancer planned to start by year-end
Dosing continues in Phase 1/2 trial of CORT125281 plus Xtandi (enzalutamide) in patients with metastatic castration-resistant prostate cancer
"Our clinical programs continue to make significant progress," said Robert S. Fishman, MD, Corcept’s Chief Medical Officer. "CORT118335 was well-tolerated in its Phase 1 trial. This compound is very potent in animal models of antipsychotic-induced weight gain and NASH – serious, widespread disorders for which patients have no good treatment options. We plan to open placebo-controlled, Phase 2 trials in both indications early next year.

"We are also excited to advance relacorilant as a treatment for solid tumors," said Dr. Fishman. "Our Phase 1/2 trial of relacorilant plus Abraxane has produced encouraging data. At ASCO (Free ASCO Whitepaper) earlier this year we reported that four of nine patients with metastatic pancreatic cancer who received the minimum therapeutic dose exhibited durable disease control, as did four of seven patients with metastatic ovarian cancer – notable results in patients with such dire disease, all of whom had progressed on prior taxane-based therapies. By year-end, we plan to open a controlled Phase 2 trial in patients with metastatic ovarian cancer and to have collected sufficient data in patients with metastatic pancreatic cancer to determine if a pivotal trial is warranted."

Conference Call

We will hold a conference call on November 1, 2018, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, dial 877-260-1479 from the United States or 334-323-0522 internationally approximately ten minutes before the start of the call (passcode: 7489528). A replay will be available through November 15, 2018 at 888-203-1112 from the United States and 719-457-0820 internationally (passcode: 7489528).

Hypercortisolism

Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the stress hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients being diagnosed each year. Symptoms vary, but most people experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Cushing’s syndrome can affect every organ system in the body and can be lethal if not treated effectively. Our first approved product, Korlym, inhibits the effects of excess cortisol by modulating activity at the glucocorticoid receptor, one of the two receptors to which cortisol binds. Korlym was the first FDA-approved treatment for patients with Cushing’s syndrome.

On November 1, 2018 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported its financial results for the third quarter ended September 30, 2018 (Press release, Puma Biotechnology, NOV 1, 2018, View Source [SID1234530615]). Unless otherwise stated, all comparisons are for the third quarter 2018 compared to the third quarter 2017.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Net product revenue in the third quarter of 2018 was $52.6 million, compared to net product revenue of $6.1 million in the third quarter of 2017. Puma Biotechnology received approval from the U.S. Food and Drug Administration (FDA) for NERLYNX (neratinib) for the treatment of early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy on July 17, 2017, and the Company began shipment to wholesalers at the end of July 2017.

Based on generally accepted accounting principles in the United States (GAAP), Puma reported a net loss applicable to common stock of $14.2 million, or $0.37 per share, for the third quarter of 2018, compared to a net loss applicable to common stock of $77.2 million, or $2.07 per share, for the third quarter of 2017. Net loss applicable to common stock for the first nine months of 2018 was $82.9 million, or $2.19 per share, compared to $227.9 million, or $6.15 per share, for the first nine months of 2017.

Non-GAAP adjusted net income was $6.6 million, or $0.17 per basic share and $0.16 per diluted share, for the third quarter of 2018, compared to non-GAAP adjusted net loss of $50.7 million, or $1.36 per share, for the third quarter of 2017. Non-GAAP adjusted net loss for the first nine months of 2018 was $14.5 million, or $0.38 per basic and diluted share, compared to non-GAAP adjusted net loss of $144.7 million, or $3.90 per share, for the first nine months of 2017. Non-GAAP adjusted net income (loss) excludes stock-based compensation expense, which represents a significant portion of overall expense and has no impact on the cash position of the Company. For a reconciliation of GAAP net loss to non-GAAP adjusted net income (loss) and GAAP net loss per share to non-GAAP adjusted net income (loss) per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the third quarter of 2018 was $7.3 million. Net cash used in operating activities for the first nine months of 2018 was $31.2 million. At September 30, 2018, Puma had cash and cash equivalents of $68.3 million and marketable securities of $59.7 million, compared to cash and cash equivalents of $81.7 million at December 31, 2017.

"The third quarter of 2018 marked the achievement of another important milestone for Puma with the European Commission granting marketing authorisation for NERLYNX for the extended adjuvant treatment of hormone receptor positive HER2-positive early stage breast cancer," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We expect this new medicine to be commercially available to patients in Europe in 2019, beginning with the expected launch in Germany during the first half of 2019 and followed by additional countries throughout Europe in the second half of 2019."

"We also continue to drive toward expanding availability of NERLYNX throughout the world," Mr. Auerbach added. "In the third quarter, our New Drug Submission was accepted in Canada, and our

licensing partner in China, CANbridge Pharmaceutical Inc., received confirmation that the country’s National Medical Products Administration accepted its New Drug Application for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, following adjuvant trastuzumab based-therapy."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) reporting data from the Phase III NALA trial in third-line metastatic breast cancer patients in the fourth quarter of 2018 or first half of 2019; (ii) submitting for regulatory approval of NERLYNX for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries in the fourth quarter of 2018 and first half of 2019; (iii) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2018; (iv) reporting additional data from the Phase II SUMMIT trial in the fourth quarter of 2018 or first half of 2019; and (v) meeting with the FDA in the first quarter of 2019 to discuss the clinical development and regulatory strategy for neratinib in HER2 mutated cancers based on the results of the ongoing SUMMIT Phase II trial."

Revenue

Total revenue consists of net product revenue from sales of NERLYNX, Puma’s first and only commercial product to date, and license revenue. For the third quarter of 2018, total revenue was $62.6 million, of which $52.6 million was net product revenue and $10.0 million was license revenue received from one of Puma’s sub-licensees. For the first nine months of 2018, total revenue was $179.9 million, of which $139.4 million was net product revenue and $40.5 million was license revenue. The FDA approved NERLYNX for commercial sale in the United States in July 2017 and Puma commenced shipment to wholesalers in late July.

Operating Costs and Expenses

Operating costs and expenses were $73.9 million for the third quarter of 2018, compared to $83.5 million for the third quarter of 2017. Operating costs and expenses for the first nine months of 2018 were $256.0 million, compared to $234.9 million for the first nine months of 2017.

Cost of Sales:

Cost of sales was $9.0 million for the third quarter of 2018 and $24.3 million for the first nine months of 2018, compared to $1.5 million for the third quarter and first nine months of 2017. The Company had no product sales prior to the third quarter of 2017.

Selling, General and Administrative Expenses:

Selling, general and administrative expenses were $28.5 million for the third quarter of 2018, compared to $32.5 million for the third quarter of 2017. SG&A expenses for the first nine months of 2018 were $105.2 million, compared to $75.8 million for the first nine months of 2017. The $29.4 million year-to-date increase was attributable to increases of approximately $26.9 million in internal expenses, such as payroll and payroll-related expenses attributable to the addition of a salesforce since the third quarter of 2017. External expenses declined approximately $1.5 million during the same time period and employee stock-based compensation increased approximately $4.0 million, primarily related to the addition of sales staff to support the commercial launch of NERLYNX in the United States. Puma expects SG&A expenses in 2018 and into 2019 to remain higher than in 2017 as it markets NERLYNX commercially in the United States and launches the product in other territories.

Research and Development Expenses:

Research and development (R&D) expenses were $36.4 million for the third quarter of 2018, compared to $49.5 million for the third quarter of 2017. R&D expenses for the first nine months of 2018 were $126.5 million, compared to $157.5 million for the first nine months of 2017. The $31.0 million year-to-date decrease resulted primarily from decreases of approximately $18.9 million in stock-based compensation and of approximately $15.4 million for external expenses related to clinical trials, manufacturing and logistics associated with clinical supply. Puma expects R&D expenses in 2018 to continue to decline slightly when compared with R&D expenses in 2017 based on a decline in clinical trial activities as existing trials continue to wind down.

On November 1, 2018 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results and provided a business update for the three months ended September 30, 2018 (Press release, Lexicon Pharmaceuticals, NOV 1, 2018, View Source;2018.htm [SID1234530613]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"In the third quarter, we and our collaborator, Sanofi, have been working diligently with regulatory agencies to make sotagliflozin available for patients with type 1 diabetes as quickly as possible and we continue to make progress in growing XERMELO for its current indication," said Lonnel Coats, Lexicon’s president and chief executive officer. "Our collaborator, Ipsen, continues to gain approvals and market authorizations for XERMELO in Europe. We are making good progress on our pipeline. By end of year, we expect to start a clinical trial for telotristat ethyl, the investigational form of XERMELO, in biliary tract cancer as well as announce data for LX2761 in diabetes and LX9211, a neuropathic pain candidate, in healthy volunteers."

Third Quarter Product and Pipeline Highlights

XERMELO (telotristat ethyl) 250 mg

•
XERMELO was approved in Australia in September for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by somatostatin analog (SSA) therapy.
•
In the third quarter, Ipsen launched XERMELO in several European countries including Sweden and Switzerland.

Sotagliflozin

•
In September, clinical data for sotagliflozin were presented at the European Association for the Study of Diabetes (EASD) 54th annual meeting. Data from patient exit interviews from a sotagliflozin Phase 3 study were also presented, reporting meaningful improvements in patient reported outcomes.

Third Quarter 2018 Financial Highlights

Revenues: Revenues for the three months ended September 30, 2018 decreased to $6.9 million from $26.9 million for the corresponding period in 2017, primarily due to lower revenues recognized from the collaboration and license agreement with Sanofi, partially offset by an increase in net product revenues. Net product revenues for the three months ended September 30, 2018 included $6.3 million from net sales of XERMELO in the U.S., up 19% from the prior year quarter and 5% from the second quarter of 2018.

Cost of Sales: Cost of sales related to sales of XERMELO for each of the three months ended September 30, 2018 and 2017 was $0.6 million.

Research and Development (R&D) Expenses: Research and development expenses for the three months ended September 30, 2018 decreased to $13.8 million from $39.1 million for the corresponding period in 2017, primarily due to lower external clinical development costs relating to sotagliflozin.

Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the three months ended September 30, 2018 decreased to $15.6 million from $16.7 million for the corresponding period in 2017, primarily due to decreased marketing costs.

Net Loss: Net loss for the three months ended September 30, 2018 was $27.5 million, or $0.26 per share, compared to a net loss of $30.7 million, or $0.29 per share, in the corresponding period in 2017. For the three months ended

September 30, 2018 and 2017, net loss included non-cash, stock-based compensation expense of $2.9 million and $2.6 million, respectively.

Cash and Investments: As of September 30, 2018, Lexicon had $187.3 million in cash and investments, as compared to $310.8 million as of December 31, 2017.

Anticipated Near-Term Milestones

•
4Q 2018 – Phase 1b data for LX2761 in type 2 diabetes
•
4Q 2018 – Phase 1a data for LX9211 (neuropathic pain candidate) in healthy volunteers
•
4Q 2018 – Initiation of clinical development of telotristat ethyl in biliary tract cancer
•
March 22, 2019 – PDUFA date for sotagliflozin in type 1 diabetes

Conference Call and Webcast Information

Lexicon management will hold a live conference call and webcast today at 8:00 am EDT / 7:00 am CDT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is 888-645-5785 (U.S./Canada) or 970-300-1531 (international). The conference ID for all callers is 6394419. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/investors. An archived version of the webcast will be available on the website for 14 days.

About XERMELO (telotristat ethyl)

Discovered using Lexicon’s unique approach to gene science, XERMELO (telotristat ethyl) is the first and only approved oral therapy for carcinoid syndrome diarrhea in combination with SSA therapy in adults inadequately controlled by SSAs. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. Lexicon has built the in-house capability and infrastructure to launch and market XERMELO in the U.S., where it retains all commercialization rights. Lexicon also retains rights to market XERMELO in Japan. Lexicon has established a license and collaboration agreement with Ipsen to commercialize XERMELO in Europe and other countries outside of U.S. and Japan.

XERMELO was approved by the U.S. Food and Drug Administration on February 28, 2017 and by the European Commission on September 19, 2017 for the treatment of carcinoid syndrome diarrhea in combination with SSA therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with metastatic NETs (mNETs) and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

XERMELO (telotristat ethyl) Important Safety Information

•
Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
•
Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
•
Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.

For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

About Sotagliflozin

Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an investigational oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney.

Lexicon entered into a collaboration and license agreement with Sanofi in November 2015 under which Lexicon granted Sanofi an exclusive, worldwide (excluding Japan), royalty-bearing right and license to develop, manufacture and commercialize sotagliflozin. Lexicon is responsible for all clinical development activities relating to type 1 diabetes and has exercised an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialization of sotagliflozin for the treatment of type 1 diabetes in the U.S. Sanofi is responsible for all clinical development and commercialization of sotagliflozin for the treatment of type 2 diabetes worldwide (excluding Japan) and is solely responsible for the commercialization of sotagliflozin for the treatment of type 1 diabetes outside the U.S. (excluding Japan). A New Drug Application and a Marketing Authorization Application for sotagliflozin are currently under review at the U.S. Food and Drug Administration and the European Medicines Agency, respectively, and the product has not yet been approved for use in the U.S. or in Europe.

On November 1, 2018 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (Nasdaq: EGRX) reported its financial results for the three and nine months ended September 30, 2018 (Press release, Eagle Pharmaceuticals, NOV 1, 2018, View Source [SID1234530583]). Highlights of and subsequent to the third quarter of 2018 include:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Business and Recent Highlights:

Commenced a $50.0 million accelerated share repurchase (the "ASR") as part of a new $150.0 million share repurchase authorization;
Announced that the Company’s fulvestrant formulation did not meet the primary bioequivalence endpoints evaluating Eagle’s formulation compared to FASLODEX in its open label, randomized, pharmacokinetic ("PK") and safety study conducted in 600 healthy female volunteers across multiple U.S. sites;
Entered into an agreement with the United States Army Medical Research Institute of Chemical Defense ("USAMRICD"), the nation’s leading science and technology laboratory in the area of medical chemical countermeasures research and development, to conduct a study to evaluate the neuroprotective effects of RYANODEX (dantrolene sodium);
Appointed David Pernock to the position of Chief Operating Officer;
Completed enrollment of the Company’s second clinical study to further evaluate the safety and efficacy of RYANODEX for the treatment of exertional heat stroke ("EHS"), an investigational new indication for the product;
Named to the Fortune 100 List of Fastest-Growing Companies, ranking 16th overall, including achieving the #1 positions for EPS 3-year growth of 392% and revenue 3-year growth of 109%; and
United States Patent and Trademark Office ("USPTO") issued patent number 10,052,385 for BENDEKA. The USPTO has now issued or allowed a total of 16 patents in the BENDEKA family of patents expiring from 2026 to 2033.
Financial Highlights:

Third Quarter 2018

Total revenue for the third quarter of 2018 was $51.3 million, compared to $63.0 million in the third quarter of 2017, which included a $12.5 million milestone payment for BENDEKA;
Eagle launched bendamustine hydrochloride 500ml solution ("Big Bag") on May 15, 2018 and Big Bag product sales were $8.0 million in the third quarter of 2018; for the week ending October 19, 2018, the Company achieved market share of 5% according to IMS Health;
Q3 2018 RYANODEX product sales were $3.5 million, up 9% compared to Q3 2017;
Q3 2018 net income was $14.0 million, or $0.94 per basic and $0.91 per diluted share, compared to net income of $15.4 million, or $1.03 per basic and $0.98 per diluted share in Q3 2017;
Q3 2018 Adjusted Non-GAAP net income was $18.3 million, or $1.22 per basic and $1.18 per diluted share, compared to Adjusted Non-GAAP net income of $19.2 million, or $1.27 per basic and $1.22 per diluted share in Q3 2017; and
Cash and cash equivalents were $91.2 million, accounts receivable was $78.5 million, and debt was $45.0 million as of September 30, 2018.
Reiterating 2018 Expense Guidance:
R&D expense is expected to be in the range of $46.0 – $50.0 million ($40.0 – $44.0 million on a non-GAAP basis)
SG&A expense is expected to be in the range of $61.0 – $64.0 million ($44.0 – $47.0 million on a non-GAAP basis)
"While we were disappointed in the outcome of the fulvestrant trial, we believe in the strength of the remaining products in our pipeline and our ability to generate long-term meaningful earnings. We are conducting a confirmatory study with the U.S. military to evaluate RYANODEX as a treatment for nerve agent exposure and continue to make progress on an intramuscular formulation. And, we maintain a positive view of a potential exertional heat stroke application. We are also advancing our vasopressin and pemetrexed assets. Consequently, we have decided to expand our share repurchase program to $150 million," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

"The $50 million of Eagle stock we purchased as part of an ASR represents the confidence of management and the Board of Directors in the value we are building at Eagle. As a publicly traded company, Eagle has raised an aggregate $110 million of equity capital. With the ASR completed, as of November 1, 2018, we have now repurchased $154 million of Eagle stock, without levering the balance sheet. With a strong base business, an exciting pipeline and growing cash position, we expect to continue building long-term value for shareholders," concluded Tarriff.

Third Quarter 2018 Financial Results

Total revenue for the three months ended September 30, 2018 was $51.3 million, as compared to $63.0 million for the three months ended September 30, 2017. Royalty revenue was $35.2 million, compared to $43.6 million in the third quarter of 2017. BENDEKA royalties were $33.8 million, compared to $41.4 million in the third quarter of 2017. A summary of total revenue is outlined below:

Research and development expenses decreased to $6.0 million for the third quarter of 2018, compared to $9.0 million in the third quarter of 2017. The year over year decrease reflects a substantial reduction in fulvestrant and pemetrexed expenses in the third quarter of 2018, partially offset by the cost of the EHS trial. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the third quarter of 2018 was $5.0 million.

SG&A expenses decreased to $13.9 million in the third quarter of 2018 compared to $16.7 million in the third quarter of 2017. The year over year decrease reflects lower external legal costs as well as a reduction in EHS marketing expenses. Excluding stock-based compensation and other non-cash and non-recurring items, third quarter 2018 SG&A expense was $9.7 million.

Net income for the third quarter of 2018 was $14.0 million, or $0.94 per basic and $0.91 per diluted share, compared to net income of $15.4 million, or $1.03 per basic and $0.98 per diluted share in the three months ended September 30, 2017, due to the factors discussed above.

Adjusted Non-GAAP net income for the third quarter of 2018 was $18.3 million, or $1.22 per basic and $1.18 per diluted share, compared to Adjusted Non-GAAP net income of $19.2 million or $1.27 per basic and $1.22 per diluted share in the third quarter of 2017. For a full reconciliation of Adjusted Non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release.

Liquidity

As of September 30, 2018, the Company had $91.2 million in cash and cash equivalents and $78.5 million in net accounts receivable, $53.2 million of which was due from Teva Pharmaceutical Industries Ltd. The Company had $45.0 million in outstanding debt.

In the third quarter of 2018, we purchased $12.1 million of Eagle’s common stock as part of our expanded $100 million share buyback program. From August 2016 through November 1, 2018, we have repurchased $154.0 million of our common stock, including the $50.0 million ASR. As disclosed on October 30, 2018, the Company’s Board of Directors retired the prior share repurchase program and approved a new $150.0 million share repurchase authorization (including the entry into the ASR).

Conference Call

As previously announced, Eagle management will host its third quarter 2018 conference call as follows:

Date Thursday, November 1, 2018
Time 8:30 A.M. EDT
Toll free (U.S.) 877-876-9173
International 785-424-1669
Webcast (live and replay)
www.eagleus.com, under the "Investor + News" section

A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-2459 (US) or 402-220-7218 (International) and entering conference call ID EGRXQ318. The webcast will be archived for 30 days at the aforementioned URL.