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!

On May 9, 2019 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported financial results for the three months ended March 31, 2019 (Press release, Quanterix, MAY 9, 2019, View Source [SID1234536058]).

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!

"We’ve made strong progress over the past quarter, which now marks our sixth consecutive quarter since the IPO of accelerated growth. In addition, we are achieving important goals in neurology and now oncology with the launch of our new SP-X Imaging and Detection System" said Kevin Hrusovsky, Chief Executive Officer, President and Chairman, Quanterix. "There is mounting evidence supporting our Simoa technology’s potential to transform virtually every category of medicine. The extreme precision and sensitivity of our expanding portfolio of instruments and platforms is fueling new insights on drug targets, disease progression biomarkers and new opportunities for patient stratification for clinical trials, transforming traditional approaches to drug development and precision medicine."

First Quarter 2019 Financial Highlights

Key financial results for the first quarter are shown below:

·Q1 revenue of $12.3M versus prior year Q1 of $7.5M, an increase of 64%.

·Q1 instrument revenue of $3.4M versus prior year Q1 of $2.0M, an increase of 70%.

·Q1 consumables revenue was $6.1M versus prior year Q1 of $2.7M, an increase of 124%.

· Q1 Service and Other revenue totaled $2.8M versus prior year Q1 of $2.5M, an increase of 11%.

·Q1 gross margin was 48.7%, a 650 basis point improvement over the 42.2% in Q1 2018.

First Quarter 2019 Business Highlights

·Extended its footprint in oncology with the accelerated launch of its Simoa SP-X Imaging and Detection System, 10-Plex Simoa CorPlex Cytokine Panel, and broad menu of additional multiplex panels to further revolutionize cancer research, immunotherapy monitoring, and drug development.

·Expanded its leadership team with the hiring of Amol Chaubal as Chief Financial Officer (CFO), formerly the CFO of Global Operations at Smith & Nephew and North America CFO – Novartis Vaccines & Diagnostics, bringing with him more than 20 years of experience in diagnostics, pharmaceutical services and medical devices.

· Increased citations in peer-reviewed publications of scientific research further validating Simoa’s capabilities in oncology and neurology with several groundbreaking studies, including a seminal study in Nature, which used Simoa to show that the biomarker LIF can be a reliable marker to help monitor the progression of pancreatic cancer. This was widely covered for its potential to help diagnose the disease more quickly and efficiently, and was proposed as a promising new target to assist in drug development. Another study using Simoa was published in Nature showing that elevated Nf-L levels were present in blood 16 years before the diagnosis of Alzheimer’s disease, demonstrating promise as part of an earlier diagnostic work-up. In total, Quanterix increased its number of third-party, peer-reviewed publications by 61, its strongest quarter ever, to a total of more than 500.

·Presented at the 37th Annual J.P. Morgan Healthcare Conference for the third year in a row, detailing Quanterix’ significant growth in its first year since becoming a public company.

· Presented and sponsored exhibits at critical industry conferences on the vital role of biomarkers to advance disease detection and therapeutics, including the 14th Annual Biomarkers Congress, Type 2 Immunity in Homeostasis and Disease, Molecular Med Tri-Con, 8th Global Reverse Phase Protein Array Workshop, the 14th International Conference on Alzheimer’s and Parkinson’s Diseases and American Association for Cancer Research (AACR) (Free AACR Whitepaper) Conference.

·Invited to speak at leading healthcare investor conferences including the 21st Annual Needham Growth Conference, the 8th Annual Leerink Partners Global Healthcare Conference, and the 39th Annual Cowen and Company Health Care Conference.

·Served as lead sponsor of the Boston, Mass. screening of "VINCIBLE The Documentary" — an inspiring true story that profiles the lives of several young adult cancer survivors who have lost their youth to the devastating disease.

Conference Call

In conjunction with this announcement, Quanterix Corporation will host a conference call on May 9, 2019, at 4:30 p.m., EDT to discuss the Company’s financial results and business outlook. To access this call, dial (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following conference ID: 8955828.

A live webcast will be accessible on the Investors section of Quanterix’ website: View Source The webcast will be available on the Company’s website for one year following completion of the call.

On May 9, 2019 Coherus BioSciences, Inc. ("Coherus" or "the Company", Nasdaq: CHRS), reported financial results for the quarter ended March 31, 2019 (Press release, Coherus Biosciences, MAY 9, 2019, View Source [SID1234536057]).

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!

First Quarter 2019 Company Highlights

UDENYCA (pegfilgrastim-cbqv) Launch Performance Consistent with Plan

Net product revenue for the first quarter of 2019 was $37.1 million following Coherus’ successful launch of UDENYCA in the U.S. marketplace on January 3, 2019.

Uptake of UDENYCA in 340B hospitals, non-340B hospitals and community oncology clinics is in line with the Company’s expectations.

UDENYCA launch performance validates its broad value proposition approach and the commercial strategy Coherus implemented. This comprehensive branded biosimilar approach leverages Coherus’ robust commercial infrastructure and its comprehensive support services program, Coherus Complete www.coheruscomplete.com.

The Company secured transitional pass-through status in 340B hospitals from CMS effective April 1, 2019, granted for a period of 36 months, incentivizing access to UDENYCA for Medicare patients.

The Company secured a $75 million credit financing with Healthcare Royalty Partners to accelerate the manufacturing and launch of UDENYCA.

Legal Developments

Coherus and Amgen settled the trade secret action brought by Amgen and Coherus continues to commercialize UDENYCA across all segments.

The Company announced a global settlement with AbbVie securing rights to commercialize its adalimumab biosimilar candidate, CHS-1420, affording a U.S. market entry date of December 15, 2023.

The Company announced the filing of a patent infringement suit against Amgen directed to Amgen’s Humira biosimilar formulation.

First Quarter 2019 Financial Results

Net product revenue for the first quarter of 2019 was $37.1 million. Cost of goods sold for the first quarter of 2019 was $2.2 million, resulting in a gross profit margin of 94 percent for the first quarter of 2019.

Research and development (R&D) expenses for the first quarter of 2019 were $18.8 million, as compared to $25.5 million for the same period in 2018. The decreases in R&D expenses were mainly due to the capitalization of UDENYCA manufacturing in the first quarter of 2019.

Selling, general and administrative (SG&A) expenses for the first quarter of 2019 were $32.7 million, as compared to $16.6 million for the same period in 2018. The increase in SG&A expenses in 2019, which was mainly attributable to the costs associated with commercializing UDENYCA in the U.S.

Total operating expenses decreased by $6.8 million from $60.5 million in the fourth quarter of 2019 to $53.7 million in the first quarter of 2019 primarily as a result of a reduction in UDENYCA manufacturing pre-approval activities.

Cash and cash equivalents and investments in marketable securities for the first quarter totaled $96.4 million as of March 31, 2019, as compared to $95.2 million as of March 31, 2018, and $72.4 million as of December 31, 2018.

Net loss attributable to the Company for the first quarter of 2019 was ($20.0) million, or ($0.29) per share, compared to a net loss of ($44.3) million, or ($0.74) per share, for the same period in 2018.

Guidance for the Next Nine Months from March 31, 2019

UDENYCA (pegfilgrastim-cbqv) biosimilar to Neulasta (pegfilgrastim)

Increase the breadth and depth of adoption across all market segments.

Secure reimbursement coverage among remaining national and regional payers.

CHS-1420, biosimilar candidate to Humira (adalimumab)

Pursue manufacturing objectives in support of the anticipated filing of a 351(k) biologic license application (BLA) in the U.S.

CHS-3351, biosimilar candidate to Lucentis (ranibizumab) and CHS-2020, biosimilar candidate to Eylea (aflibercept)

Complete manufacturing technology transfer to support clinical development of CHS-3351.

Continue preclinical development of CHS-2020.

CHS-131, small molecule, PPAR-g modulator drug candidate in nonalcoholic steatohepatitis ("NASH")

Initiate clinical phase program in NASH.

Conference Call Information

When: Thursday, May 9, 2019 starting at 4:30 p.m. ET

Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (international)

Conference ID: 2969536

Webcast: View Source

You will be asked to register when you join the call. The webcast will be archived on the Coherus website.

About UDENYCA

UDENYCA (pegfilgrastim-cbqv) is a PEGylated growth colony-stimulating factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. UDENYCA drug substance manufacturing is located in Boulder, Colorado. Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of $4.5 billion in 2017.

Indication

UDENYCA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitations of Use

UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

IMPORTANT SAFETY INFORMATION

Contraindication

Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products.

Warnings and Precautions

Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.

Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA in patients with ARDS.

Serious allergic reactions, including anaphylaxis: Permanently discontinue UDENYCA in patients with serious allergic reactions.

Fatal sickle cell crises: Have occurred.

Glomerulonephritis: Evaluate and consider dose-reduction or interruption of UDENYCA if causality is likely.

Adverse Reactions

Most common adverse reactions (³ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences, Inc. at 1-800-4-UDENYCA (1-800-483-3692) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

On May 9, 2019 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, reported its financial results for the quarter ended March 31, 2019 (Press release, Corcept Therapeutics, MAY 9, 2019, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-first-quarter-2019-financial [SID1234536056]).

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 $64.8 million, a 12 percent increase from first quarter 2018
Fully-diluted GAAP net income of $0.15 per share, compared to $0.14 per share in first quarter 2018
Fully-diluted non-GAAP net income of $0.20 per share, compared to $0.19 per share in first quarter 2018
Cash and investments of $215.7 million, a $9.0 million increase from year-end 2018
Reaffirmed 2019 revenue guidance of $285 – $315 million
Corcept reported quarterly revenue of $64.8 million, compared to $57.7 million in the first quarter of 2018. First quarter GAAP net income was $18.3 million, compared to $17.5 million in the same period last year. Excluding non-cash expenses related to stock-based compensation, utilization of deferred tax assets and related income tax effects, non-GAAP net income in the first quarter was $24.3 million, compared to $24.5 million in the first quarter of 2018. A reconciliation of GAAP to non-GAAP net income is included below.

First quarter operating expenses were $45.9 million, compared to $36.7 million in the first quarter of 2018, primarily due to an increase in research and development personnel and increased spending to advance new compounds towards the clinic and to formulate and manufacture relacorilant, CORT118335 and CORT125281.

Cash and investments were $215.7 million at March 31, 2019, an increase of $9.0 million from year-end. This increase was after the expenditure of $13.6 million in the first quarter to repurchase 1.2 million shares of common stock. At March 31, 2019, $62.8 million remained available under Corcept’s stock repurchase program.

The company reaffirmed 2019 revenue guidance of $285 – $315 million.

"As in prior years, our first quarter revenue was reduced as payors forced patients to secure reauthorization of their insurance," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "Our first quarter revenue was also reduced by the requirement that we cover a portion of the ‘donut hole’ in Medicare Part D insurance plans – a portion that, by statute, increased significantly this year. No patient’s care was interrupted, because we provide Korlym at no cost until coverage is restored. The number of patients receiving Korlym continues to grow.

"Awareness of Cushing’s syndrome and the importance of screening more widely for the disorder is increasing," Dr. Belanoff added. "Our goal is to educate physicians about the benefits of cortisol modulation with Korlym and, should it continue to generate positive clinical data and we secure FDA approval, relacorilant, Korlym’s planned successor. We believe relacorilant has the potential to offer significant benefits – even beyond what we see with Korlym."

Clinical Highlights

Dosing continues in Phase 3 trial of relacorilant in patients with Cushing’s syndrome ("GRACE")
European Medicines Agency ("EMA") recommends orphan designation for relacorilant to treat patients with Cushing’s syndrome
Dosing initiated in double-blind, placebo-controlled, Phase 1b trial of CORT118335 for prevention of antipsychotic-induced weight gain; Phase 2 trials in reversal of antipsychotic-induced weight gain planned in second half of 2019
Placebo-controlled, Phase 2 trial of CORT118335 to treat non-alcoholic steatohepatitis ("NASH") planned in second half of 2019
Data from Phase 1/2 trial of relacorilant plus Abraxane in solid tumors to be presented at 2019 ASCO (Free ASCO Whitepaper) Meeting, May 31 – June 4
Dosing continues in controlled, Phase 2 trial of relacorilant plus Abraxane in metastatic ovarian cancer
Dosing continues in Phase 1/2 trial of CORT125281 plus Xtandi in castration-resistant prostate cancer
"It is an exciting time to join Corcept," said Andreas Grauer, MD, who became Corcept’s Chief Medical Officer in March 2019. "Three of our proprietary, selective cortisol modulators have entered the clinic and we are conducting five clinical trials – in Cushing’s syndrome, solid tumors and antipsychotic-induced weight gain. Additional trials – in antipsychotic-induced weight gain and NASH – are planned for later in the year."

"Relacorilant’s GRACE trial continues to dose patients with Cushing’s syndrome and has begun opening sites in Europe, where many of our Phase 2 patients were enrolled. The EMA’s recommendation that relacorilant receive orphan drug designation is especially gratifying. Unlike in the United States, orphan designation in Europe requires the authorities to find plausible evidence of a drug’s efficacy and potential to confer significant clinical benefit compared to already-approved treatments – findings we hope GRACE will confirm for relacorilant." (For more about GRACE, go to cushingresearch.com.)

Corcept presented data from relacorilant’s Phase 2 trial at the 2019 annual meeting of the American Association of Clinical Endocrinologists ("AACE") in April. Subjects in the trial exhibited clinically meaningful improvements in the trial’s key endpoints – hypertension and glucose control – and in a variety of secondary endpoints, including weight loss, liver function, coagulopathy, insulin resistance, cognitive function, mood and quality of life. Relacorilant was well-tolerated, with the most common adverse events being those associated with a reduction in excess cortisol activity. These side effects usually resolve with continued treatment. There were no instances of abnormal vaginal bleeding, even in women who had previously experienced abnormal vaginal bleeding with Korlym. Importantly, there were no instances of hypokalemia, an adverse event experienced by 44 percent of patients in Korlym’s pivotal trial and a leading cause of Korlym discontinuation. (Corcept’s AACE presentation is available at ir.corcept.com/events.)

"Our oncology program is also progressing," said Dr. Grauer. "Enrollment has begun in our 180-patient, controlled, Phase 2 trial of relacorilant plus Abraxane in patients with metastatic ovarian cancer. At the ASCO (Free ASCO Whitepaper) congress this June, we will present data from our Phase 1/2 trial of relacorilant plus Abraxane in a variety of solid tumors and discuss our plans in metastatic pancreatic cancer."

"Finally, our most promising compound for metabolic disorders, CORT118335, has entered the clinic. We are dosing healthy subjects in a placebo-controlled Phase 1b trial in the prevention of antipsychotic-induced weight gain and plan to start two placebo-controlled, Phase 2 trials in patients later this year, as well as a placebo-controlled, Phase 2 trial in patients with NASH – a precursor of cirrhosis. These disorders afflict millions of patients and there are no good treatment options."

Conference Call
We will hold a conference call on May 9, 2019, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, dial 1-800-347-6311 from the United States or 1-323-994-2132 internationally approximately ten minutes before the start of the call. The passcode will be 4773625. A replay will be available through May 23, 2019 at 888-203-1112 in the United States and 719-457-0820 internationally. The passcode will be 4773625.

Hypercortisolism
Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the 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. Hypercortisolism can affect every organ system in the body and can be lethal if not treated effectively.

On May 9, 2019 NantHealth, Inc. (NASDAQ-GS: NH), a next-generation, evidence-based, personalized healthcare company, reported financial results for its first quarter ended March 31, 2019 (Press release, NantHealth, MAY 9, 2019, View Source;p=RssLanding&cat=news&id=2398133 [SID1234536055]).

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!

"We had an excellent start to fiscal 2019," said Bob Petrou, Chief Financial Officer of NantHealth. "Our solid 2019 first quarter results were driven by higher total revenue combined with an improved gross margin. Our SaaS business, which comprises the largest portion of our operations, continued its sequential quarterly topline growth, and with the recent signing of a multi-year contract for our Eviti clinical decision support solution, we expect to continue to see further revenue growth."

Software and Services Highlights:

Clinical Decision Support (Eviti):
In Q2, signed a three-year partnership with a leading nonprofit multi-state health plan, expanding Eviti Connect’s total covered lives to over 25 million
In Q1, released versions 7.6 and 7.7, with the following enhancements:
Added features that alert payers when a patient begins treatment before eligibility is determined
Clinical content teams can now publish regimens more efficiently and effectively to meet client needs
Payer medical management groups can now customize warnings and deviations for their clinically equivalent programs
Payers are now provided with superior insights into member eligibility and treatment timeframes
Payer Engagement (NaviNet):
In Q1, implemented refreshed pricing for NaviNet AllPayer services, which is expected to drive enhanced SaaS financial performance in 2019
In Q1, enhanced new workflow capabilities within the Authorizations applications to support functionality in submission workflow, and updated the Authorization Appeals application to better support users
In Q1, upgraded the Claim Status Inquiry tool to allow for better visibility of actions taken within NaviNet for non-NaviNet Claims, increasing utility of the NaviNet solution beyond current payer partners
In Q1, provided health plans/payers greater efficiency by allowing enhanced customization to Open Claim attachment metadata, improving automated file retrieval and processing on their backend
Connected Care (DeviceConX):
In Q1, participated in Healthcare Information and Management Systems Society (HIMSS) Conference in Orlando, FL, showcasing the DeviceConX solution’s ability to successfully deliver GE Healthcare device data and the company’s collaborations with Dell Boomi, Baxter and other kidney dialysis treatment solutions
In Q1, significantly increased connectivity license sales, driving improved recurring maintenance revenue on a go forward basis, as previously announced
In Q1, as previously announced, deployed DeviceConX Version 5.15 upgrade, with the ability to push OS security patches directly to HBox Connected Care hardware devices
In April, the company presented its VitalsConX technology at the American Nursing Informatics Association (ANIA) Annual Conference, demonstrating the ease of collecting, inputting and integrating patient data into electronic health records (EHRs)
Sequencing and Molecular Analysis – Highlights
In Q1, total GPS orders were 820, comprised of GPS Cancer of 428 and Liquid GPS of 392
In Q1, scientific teams from NantHealth and NantOmics presented five posters at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium and two posters at the ASCO (Free ASCO Whitepaper)’s Genitourinary Cancers Symposium. The research presented focused on the significance of RNA expression, in tissue and blood, and individual biomarkers in determining why some patients do not respond to targeted cancer therapies based on DNA genomic profiling alone
Business and Financial Highlights

For the 2019 first quarter, total net revenue was $23.7 million, compared with $22.3 million in 2018 first quarter. Gross profit was $12.4 million, or 52% of total net revenue, compared with $11.2 million, or 50% of total net revenue, for the prior year period. Selling, general and administrative expenses declined to $16.8 million, from $20.7 million in 2018 first quarter. Research and development expenses decreased to $5.1 million from $5.2 million.

Financial results for the first quarter of 2019 included non-cash charges for loss from related party equity method investment and Allscripts liability of $4.7 million. Net loss from continuing operations, net of tax, was $19.8 million, or $0.18 per share, compared with $22.0 million, or $0.20 per share, for the 2018 first quarter. Net loss was $19.9 million, or $0.18 per share, compared with $22.2 million, or $0.20 per share, for 2018 first quarter.

For the 2019 first quarter, on a non-GAAP basis, adjusted net loss from continuing operations was $10.7 million, or $0.10 per share, compared with $13.5 million, or $0.12 per share, for the 2018 first quarter.

Conference Call Information and Forward-Looking Statements

Later today, the company will host a conference call at 1:30 p.m. PT (4:30 p.m. ET) to review its results of operations for the first quarter ended March 31, 2019. The conference call will be available to interested parties by dialing 844-309-3709 from the U.S. or Canada, or 281-962-4864 from international locations, passcode 6159197. The call will be broadcast via the Internet at www.nanthealth.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

Discussion during the conference call may include forward-looking statements regarding topics such as the company’s financial status and performance, regulatory and operational developments, and other comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

Use of Non-GAAP Financial Measures

This news release contains references to Non-GAAP financial measures, including adjusted net loss and adjusted net loss per share, which are financial measures that are not prepared in conformity with United States generally accepted accounting principles (U.S. GAAP). The Company’s management believes that the presentation of Non-GAAP financial measures provides useful supplementary information regarding operational performance, because it enhances an investor’s overall understanding of the financial results for the Company’s core business. Additionally, it provides a basis for the comparison of the financial results for the Company’s core business between current, past and future periods. Other companies may define these measures in different ways. Non-GAAP financial measures should be considered only as a supplement to, and not as a substitute for or as a superior measure to, financial measures prepared in accordance with U.S. GAAP. Non-GAAP per share numbers are calculated based on one class of common stock and do not incorporate the effects, if any, of using the two-class method.