On August 5, 2020 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, reported financial results for the quarter ended June 30, 2020. (Press release, Allogene, AUG 5, 2020, View Source [SID1234562874])

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 are incredibly pleased with the progress we’ve made across our AlloCAR T platform, which now includes ongoing clinical trials for ALLO-501, ALLO-501A and ALLO-715," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "The ALLO-501 data we presented at ASCO (Free ASCO Whitepaper) in May solidifies our belief in the potential of AlloCAR T therapy in hematologic malignancies. We look forward to presenting initial data in a second hematologic malignancy, multiple myeloma, later this year as we advance the same innovative approach to solid tumors in 2021."

Recent Highlights

Anti-CD19 AlloCAR T Program
Initial data from ALLO-501’s ALPHA trial provided support for the Company’s approach to AlloCAR T therapy. Allogene intends to leverage ALLO-501 to optimize trial design and dose selection as it prepares for a potentially pivotal Phase 2 trial of ALLO-501A in 2021.

•ALLO-501 ALPHA Phase 1 Trial
In May 2020 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, the Company presented initial data from its dose escalation Phase 1 ALPHA study of ALLO-501 in relapsed/refractory non-Hodgkin lymphoma (NHL). This study utilizes ALLO-647, the Company’s anti-CD52 monoclonal antibody (mAb), as a part of its differentiated lymphodepletion regimen. The next readout from this trial is expected to be in late 2020 or early 2021.

As per the ASCO (Free ASCO Whitepaper) presentation, 22 patients were evaluable for safety and 19 patients were evaluable for efficacy with at least one tumor assessment as of the May 2020 data cutoff.
◦Responses were observed across all cell doses and NHL histologies (diffuse large B-cell lymphoma and follicular lymphoma).
◦Across all evaluable patients, there were seven complete responses (CR) and five partial responses (PR) for an overall response rate (ORR) of 63% and CR rate of 37%.
◦In CAR T naïve patients (n=16) the ORR was 75% and the CR rate 44%.
◦Higher dose ALLO-647 was associated with a higher CR rate.
◦With a median follow-up of 3.8 months, nine of the 12 responding patients (75%) remained in response as of the data cutoff on May 11, 2020.
◦No dose limiting toxicities, graft-vs-host disease, or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) was observed. Cytokine release syndrome occurred in 32% of the patients, was mainly mild to moderate

in severity and manageable with standard recommendations. Four patients (18%) experienced serious adverse events (SAE), all of which resolved.

•ALLO-501A ALPHA2 Phase 1 Trial
ALLO-501A is a next generation anti-CD19 AlloCAR T intended for Phase 2 development. During the second quarter, the Company initiated enrollment in the Phase 1 portion of the ALPHA2 trial. This abbreviated dose escalation study is a single-arm, open-label, multicenter trial of ALLO-501A in patients with R/R large B-cell lymphoma. The Company expects to begin the Phase 2 portion of this study in 2021.

Anti-BCMA AlloCAR T Program
The Company continues to progress its robust anti-BCMA strategy centered around ALLO-715 for the treatment of multiple myeloma (MM).

•ALLO-715 UNIVERSAL Phase 1 Trial
◦The ALLO-715 Phase 1 UNIVERSAL trial in patients with relapsed/refractory MM utilizes ALLO-647 as part of the lymphodepletion platform. The initial dose escalation portion of the UNIVERSAL trial using 39mg of ALLO-647 is now complete. The trial continues to enroll patients with initial data anticipated in Q4 2020.
•ALLO-715 + nirogacestat
◦An Investigational New Drug (IND) application is expected to be submitted in the second half of 2020 to evaluate ALLO-715 in combination with SpringWorks’ investigational gamma secretase inhibitor, nirogacestat, in patients with relapsed/refractory MM.
•ALLO-605 (TurboCAR)
◦The Company presented preclinical data on its internally developed TurboCAR technology platform at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 23rd Annual Meeting in May. TurboCAR technology allows cytokine activation signaling to be engineered selectively into CAR T cells. TurboCAR has the potential to improve efficacy, overcome cell exhaustion, and reduce dosing requirements of AlloCAR T therapy.
◦In 2021, an IND is expected to be submitted for the Company’s first TurboCAR candidate, ALLO-605, an investigational BCMA-directed AlloCAR T therapy for MM.

Solid Tumor AlloCAR T Program
•ALLO-316 (anti-CD70)
◦The Company continues to progress pre-clinical work on ALLO-316, its anti-CD70 AlloCAR T clinical candidate. ALLO-316 has potential application in both hematologic malignancies and solid tumors. The initial focus for this investigational therapy will be renal cell carcinoma with an IND planned by the end of 2020.
Manufacturing Updates
Construction continues on the Company’s state-of-the-art cGMP cell manufacturing facility in Newark, California. The Company continues to expect to initiate cGMP manufacturing from this facility in 2021.

Second Quarter Financial Results
•Research and development expenses were $47.3 million for the second quarter of 2020, which includes $8.0 million of non-cash stock-based compensation expense.
•General and administrative expenses were $15.9 million for the second quarter of 2020, which includes $8.8 million of non-cash stock-based compensation expense.
•Net loss for the second quarter of 2020 was $61.0 million, or $0.53 per share, including non-cash stock-based compensation expense of $16.8 million.
•In June, the Company closed on a secondary offering that raised $632.5 million in gross proceeds prior to deducting underwriting discounts, commissions and offering expenses. This included the exercise in full by the Underwriters of their option to purchase additional shares of common stock. As a result, the Company had $1.1 billion in cash, cash equivalents, and investments as of June 30, 2020.

2020 Financial Guidance
•Allogene continues to expect full year GAAP net losses to be between $260 million and $280 million including estimated non-cash stock-based compensation expense of $70 million to $75 million and excluding any impact from potential business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time to discuss financial results and provide a business update. To access the live conference call by telephone, please dial 1 (866) 940-5062 (U.S.) or 1 (409) 216-0618 (International). The conference ID number for the live call is 2189084. The webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

On August 5, 2020 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported financial results for the second quarter of 2020 and provided a business update (Press release, Regeneron, AUG 5, 2020, View Source [SID1234562873]).

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!

"I’m very proud of how the Regeneron team has continued to drive important progress for patients, despite the significant challenges of the COVID-19 pandemic," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "We have advanced REGN-COV2, our antibody cocktail for COVID-19, into late-stage clinical studies in record time and are working to ensure supply is available later this year. We are continuing to drive strong performance with our marketed medicines, including EYLEA, Dupixent, and Libtayo, while also advancing research, development, and regulatory progress across a number of therapeutic areas including cancer, Type 2 inflammatory diseases, pain, and rare diseases."

"Regeneron’s business continues to be resilient during these times, delivering double digit top- and bottom-line growth in the second quarter," said Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "Our strong balance sheet, improved competitive outlook, increasingly diversified commercial portfolio, and robust pipeline position Regeneron well for sustained long-term growth."

Key Pipeline Progress
Regeneron has more than 20 product candidates in clinical development, including five marketed products for which it is investigating additional indications. Updates from the clinical pipeline include:
EYLEA (aflibercept) Injection
•Phase 3 studies exploring less frequent dosing intervals using a high-dose formulation of aflibercept in neovascular age-related macular degeneration (wet AMD) and diabetic macular edema (DME) were initiated.
•In April 2020, the European Commission approved the EYLEA pre-filled syringe.

Dupixent (dupilumab)
•In May 2020, the U.S. Food and Drug Administration (FDA) approved Dupixent as the first biologic medicine for children aged 6 to 11 years with moderate-to-severe atopic dermatitis.
•In June 2020, the National Medical Products Administration (NMPA) in China approved Dupixent for adults with moderate-to-severe atopic dermatitis.
•In May 2020, the Company and Sanofi announced positive results from Part A of the Phase 3 trial in patients 12 years and older with eosinophilic esophagitis (EoE). The trial met both of its co-primary endpoints, as well as all key secondary endpoints.
•A Phase 3 study in pediatric patients with EoE was initiated.
•In June 2020, the FDA approved a 300 mg single-dose pre-filled pen for Dupixent.
•An ongoing Phase 3 trial in chronic obstructive pulmonary disease (COPD) patients with evidence of Type 2 inflammation met a blinded, stringent early efficacy threshold for continuation. Based on this result, a second confirmatory Phase 3 trial in COPD was initiated.

REGN-COV2
•The Company initiated clinical trials of REGN-COV2, its investigational two-antibody "cocktail" for the treatment and prevention of COVID-19.
•Following review from the Independent Data Monitoring Committee (IDMC) of REGN-COV2 Phase 1 safety results, a Phase 3 trial to evaluate REGN-COV2’s ability to prevent infection among uninfected people who have had close exposure to a COVID-19 patient (such as the patient’s housemate) was initiated and is being run jointly with the National Institute of Allergy and Infectious Diseases (NIAID). In addition, REGN-COV2 moved into the Phase 2/3 portion of two adaptive Phase 1/2/3 trials testing the cocktail’s ability to treat hospitalized and non-hospitalized patients with COVID-19. The Company plans to report initial virology and biomarker results from the REGN-COV2 treatment trials in September 2020.

•Two papers were published in Science describing the creation of REGN-COV2 and highlighting the potential of REGN-COV2 to diminish the risk of viral escape by effectively binding to the virus’s critical spike protein in two separate, non-overlapping locations.
•Non-human primate data were provided as a pre-review publication online for REGN-COV2 showing that treatment with this antibody cocktail can prevent SARS-CoV-2 infection as well as treat infected animals by accelerating viral elimination.
•The Company announced an agreement with the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Defense whereby the Company was awarded a $450 million contract to manufacture and supply filled and finished REGN-COV2 to the U.S. Government. The agreement provides for the Company to manufacture a fixed number of bulk lots beginning in the summer of 2020 and fill/finish and storage activities starting in the third quarter of 2020.

Kevzara (sarilumab)
•The Company and Sanofi reported that the Regeneron-led U.S. Phase 3 study of Kevzara 400 mg in COVID-19 patients requiring mechanical ventilation did not meet its primary and key secondary endpoints. Based on the results, the U.S.-based trial has been stopped.

Oncology Program
•In April 2020, the Company and Sanofi announced that the primary endpoint was met in the Phase 3 trial of Libtayo (cemiplimab) as monotherapy in first-line non-small cell lung cancer (NSCLC). In May 2020, the Company and Sanofi also announced that Libtayo demonstrated clinically-meaningful and durable responses in a pivotal, single-arm, open-label trial in patients with advanced basal cell carcinoma. The data from these trials will form the basis of regulatory submissions in the U.S. and European Union (EU) this year.
•In May 2020, the Company and Sanofi announced new, longer-term data for Libtayo from a pivotal Phase 2 trial in advanced cutaneous squamous cell carcinoma (CSCC). These results demonstrate both longer durability and higher complete response rates than previously reported. Updated data from this trial have also been incorporated into the U.S. label.
•A publication in Science Translational Medicine featured scientific findings highlighting the benefit demonstrated in preclinical research in combining the Company’s novel class of CD28 costimulatory bispecific antibodies with Libtayo. In 2020, the Company plans to enroll patients in clinical trials investigating three different CD28 costimulatory bispecific candidates. Regeneron’s first costimulatory bispecific trial, investigating the combination of PSMAxCD28 (REGN5678) and Libtayo for prostate cancer, is underway and has treated patients in several dose-escalation cohorts.

Praluent (alirocumab)
•The Company submitted a supplemental Biologics License Application (sBLA) for homozygous familial hypercholesterolemia (HoFH) in adults.

Evinacumab, an antibody to ANGPTL3
•The Company completed the rolling BLA submission and a Marketing Authorization Application (MAA) was also submitted for HoFH.

Fasinumab, an antibody to NGF
•Two Phase 3 trials, FACT OA1 and FACT OA2, achieved the co-primary endpoints for fasinumab 1 mg monthly, demonstrating significant improvements in pain and physical function over placebo at week 16 and week 24, respectively. Fasinumab 1 mg monthly also showed nominally significant benefits in physical function in both trials and pain in one trial, when compared to the maximum FDA-approved prescription doses of non-steroidal anti-inflammatory drugs for osteoarthritis.
•The FACT OA1 trial included an additional treatment arm, fasinumab 1 mg every two months, which showed numerical benefit over placebo, but did not reach statistical significance.
•In initial safety analyses from the Phase 3 trials, there was an increase in arthropathies reported with fasinumab. In a sub-group of patients from one Phase 3 long-term safety trial, there was an increase in joint replacement with fasinumab 1 mg monthly treatment during the off-drug follow-up period, although this increase was not seen in the other trials to date. Additional longer-term safety data from the ongoing trials are being collected and are expected to be reported early next year.

COVID-19 Business Impact Update
•Regeneron maintains adequate market supply for all commercialized products. The Company’s raw material supplies and contract manufacturing support have also remained stable.
•The Company continues to evaluate the impact of the COVID-19 pandemic on an individual clinical trial basis and expects fully-recruited clinical studies to remain generally on track. After briefly pausing new enrollment in certain studies due to the pandemic, enrollment in both new and ongoing clinical studies started to resume as regions relaxed their restrictions and healthcare resources started to become more available for non-COVID-19 activities. However, there has been a resurgence of COVID-19 cases in many regions across the world, and any resurgence in the regions in which the Company or its collaborators conduct clinical trials may require the Company to adjust its expectations relating to the impacted studies.

Corporate and Business Development Update
•The Company and Sanofi entered into an agreement, effective April 1, 2020, to restructure its collaboration for Praluent. In the United States, the Company is now solely responsible for the development and commercialization of Praluent and records net product sales. The Company does not owe Sanofi royalties on net product sales of Praluent in the United States. Sanofi has sole responsibility for the development and commercialization of Praluent outside the United States, and pays the Company a 5% royalty on Praluent net product sales.
•In May 2020, a secondary offering of approximately 13 million shares of the Company’s common stock held by Sanofi was completed. Concurrent with the secondary offering, the Company purchased approximately 9.8 million shares directly from Sanofi for an aggregate purchase amount of $5 billion. Pursuant to the offering and purchase, Sanofi disposed of all but 400,000 shares of the Company’s common stock that it retained as of the closing date of such transactions.
•In May 2020, the Company expanded its existing collaboration with Intellia Therapeutics, Inc. to provide the Company with rights to develop products for additional in vivo CRISPR/Cas9-based therapeutic targets and for the companies to jointly develop potential products for the treatment of hemophilia A and B. In addition, the Company also received non-exclusive rights to independently develop and commercialize ex vivo gene edited products. In connection with the agreement, the Company made a $70 million up-front payment and purchased Intellia common stock for $30 million.
•In July 2020, HHS exercised its option under the existing agreement for the treatment of Ebola virus infection to provide additional funding for the manufacture and supply of REGN-EB3. REGN-EB3 is currently under priority review by the FDA, with a target action date of October 25, 2020. Contingent on FDA approval, Regeneron expects to deliver an established number of treatment doses over the course of approximately six years.

Second Quarter 2020 Financial Results

Effective January 1, 2020, Regeneron has implemented changes in the presentation of its financial statements related to certain reimbursements and other payments for products developed and commercialized with collaborators. The Company made these changes in presentation to better reflect the nature of the Company’s costs incurred and revenues earned pursuant to arrangements with collaborators and to enhance the comparability of Regeneron’s financial statements with industry peers. The change in presentation has been applied retrospectively. See note (4) below for further information.

Revenues
Total revenues increased by 24% to $1.952 billion in the second quarter of 2020, compared to $1.578 billion in the second quarter of 2019.
EYLEA net product sales in the United States were $1.114 billion in the second quarter of 2020, compared to $1.160 billion in the second quarter of 2019. EYLEA’s second quarter 2020 net product sales in the United States were negatively impacted by the COVID-19 pandemic. Overall distributor inventory levels for EYLEA in the United States remained within the Company’s one-to-two-week targeted range.
Total revenues also include Sanofi and Bayer collaboration revenues(2) of $513 million in the second quarter of 2020, compared to $353 million in the second quarter of 2019. Sanofi collaboration revenue increased primarily due to the Company’s share of profits from commercialization of antibodies, which increased to $172 million in the second quarter of 2020 from $39 million in the second quarter of 2019. The change in the Company’s share of profits from collaboration antibodies was primarily driven by higher Dupixent profits.
Refer to Table 4 for a summary of collaboration revenue.
Other revenues in the second quarter of 2020 include recognition of revenue in connection with the Company’s agreements with BARDA related to funding of certain development activities for REGN-EB3 for the treatment of Ebola and antibodies for the treatment of COVID-19.
•GAAP R&D expenses in the second quarter of 2020 included $85 million in up-front payments in connection with the collaboration agreement with Intellia. GAAP R&D expenses in the second quarter of 2019 included a $400 million up-front payment in connection with the collaboration agreement with Alnylam Pharmaceuticals, Inc. Non-GAAP R&D expenses increased in the second quarter of 2020 principally due to additional costs incurred in connection with COVID-19 related development activities, higher headcount and headcount-related costs, and an increase in clinical manufacturing activities.
•The higher GAAP and non-GAAP SG&A expenses in the second quarter of 2020 were primarily due to higher headcount-related costs, higher contributions to independent not-for-profit patient assistance organizations, and the Company no longer receiving Praluent-related cost reimbursements from Sanofi.

•The increase in cost of collaboration and contract manufacturing in the second quarter of 2020 was primarily due to the recognition of manufacturing costs associated with higher sales of Dupixent, process validation costs in connection with manufacturing REGN-EB3 under the BARDA Ebola agreement, and recognition of costs in connection with manufacturing ex-U.S. commercial supplies of Praluent for Sanofi under the new agreement.
•Other operating (income) expense, net, includes recognition of a portion of amounts previously deferred in connection with up-front and development milestone payments, as applicable, received in connection with the Company’s collaborative arrangements.
Other Financial Information
GAAP other income (expense), net, includes the recognition of net unrealized gains on equity securities of $228 million in the second quarter of 2020, compared to net unrealized losses of $117 million in the second quarter of 2019. GAAP other income (expense), net, also includes the recognition of net realized gains on sales of debt securities.
In the second quarter of 2020, the Company’s GAAP effective tax rate was 2.4%, compared to 14.1% in the second quarter of 2019. The GAAP effective tax rate for the second quarter of 2020 was positively impacted, compared to the U.S. federal statutory rate, primarily by stock-based compensation, and, to a lesser extent, income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate and federal tax credits for research activities. In the second quarter of 2020, the non-GAAP effective tax rate was 0.9%, compared to 19.1% in the second quarter of 2019. The Company expects its full year 2020 GAAP effective tax rate to be 9–11% and its non-GAAP effective tax rate to be 10–12% (see financial guidance table below).
GAAP net income per diluted share was $7.61 in the second quarter of 2020, compared to GAAP net income per diluted share of $1.68 in the second quarter of 2019. Non-GAAP net income per diluted share was $7.16 in the second quarter of 2020, compared to non-GAAP net income per diluted share of $6.02 in the second quarter of 2019. A reconciliation of the Company’s GAAP to non-GAAP results is included in Table 3 of this press release.
As described above, during the second quarter of 2020, the Company purchased 9,806,805 shares of Common Stock from Sanofi and recorded the cost of the shares received, or $5 billion, as Treasury Stock.
The Company generated $943 million of net cash provided by operating activities in the second quarter of 2020, compared to $188 million in the second quarter of 2019, which led to $814 million in free cash flow for the second quarter of 2020, compared to $94 million for the second quarter of 2019.
This press release uses non-GAAP R&D, non-GAAP SG&A, non-GAAP COGS, non-GAAP other income (expense) net, non-GAAP effective tax rate, non-GAAP net income, non-GAAP net income per share, and free cash flow, which are financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles (GAAP). These non-GAAP financial measures are computed by excluding certain non-cash and/or other items from the related GAAP financial measure. The Company also includes a non-GAAP adjustment for the estimated income tax effect of reconciling items.

The Company makes such adjustments for items the Company does not view as useful in evaluating its operating performance. For example, adjustments may be made for items that fluctuate from period to period based on factors that are not within the Company’s control (such as the Company’s stock price on the dates share-based grants are issued or changes in the fair value of the Company’s equity investments) or items that are not associated with normal, recurring operations (such as restructuring-related expenses, including employee separation costs). Management uses these non-GAAP measures for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides forecasts to investors on this basis. With respect to free cash flows, the Company believes that this non-GAAP measure provides a further measure of the Company’s operations’ ability to generate cash flows. Additionally, such non-GAAP measures provide investors with an enhanced understanding of the financial performance of the Company’s core business operations. However, there are limitations in the use of these and other non-GAAP financial measures as they exclude certain expenses that are recurring in nature. Furthermore, the Company’s non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented by Regeneron should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP. A reconciliation of the Company’s historical GAAP to non-GAAP results is included in Table 3 of this press release.
(2)The Company’s collaborators provide it with estimates of the collaborators’ respective sales and the Company’s share of the profits or losses from commercialization of products for the most recent fiscal quarter. The Company’s estimates for such quarter are reconciled to actual results in the subsequent fiscal quarter, and the Company’s share of the profit or loss is adjusted on a prospective basis accordingly, if necessary.(3) The Company’s 2020 financial guidance does not assume the completion of any significant business development transactions not completed as of the date of this press release.(4)Applicable amounts previously reported for the three and six months ended June 30, 2019 and as of December 31, 2019 have been revised to reflect a change in presentation of cost reimbursements from collaborators who are not deemed to be the Company’s customers from collaboration revenue to a reduction of the corresponding operating expense. The Company also changed the presentation of amounts recognized in connection with up-front and development milestone payments received from collaboration revenue to Other operating income, as well as the presentation of the corresponding balance sheet accounts. The revisions were reclassifications only and had no impact on the Company’s previously reported GAAP and non-GAAP net income and net income per share. Refer to the Company’s Form 10-Q for the quarterly period ended June 30, 2020 (Note 1 of the Notes to Condensed Consolidated Financial Statements) for further details.(5) Corresponding reimbursements from collaborators and others for manufacturing of commercial supplies is recorded within revenues.

Conference Call Information

Regeneron will host a conference call and simultaneous webcast to discuss its second quarter 2020 financial and operating results on Wednesday, August 5, 2020, at 8:30 AM. To access this call, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International). A link to the webcast may be accessed from the "Investors and Media" page of Regeneron’s website at www.regeneron.com. A replay of the conference call and webcast will be archived on the Company’s website and will be available for at least 30 days.

On August 5, 2020 IVERIC bio, Inc. (Nasdaq: ISEE) reported financial and operating results for the fiscal quarter ended June 30, 2020 and provided a general business update (Press release, Ophthotech, AUG 5, 2020, View Source [SID1234562872]).

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!

"Following the positive results from our GATHER1 Phase 3 clinical trial of Zimura for the treatment of geographic atrophy secondary to age-related macular degeneration, our main priority is to aggressively drive patient recruitment and retention in GATHER2, our second Phase 3 clinical trial for the treatment of GA secondary to AMD," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "We believe GATHER1 is currently the only Phase 3 clinical trial showing early suppression of GA growth which continued for 18 months with continuous treatment. The enthusiasm, resiliency and dedication of patients, physicians and their staffs fueled by their confidence in the GATHER1 Phase 3 results are exceeding our expectations."

Mr. Sblendorio added, "During the second quarter, we strengthened our balance sheet with a public offering and a concurrent private placement. We believe this enables us to further execute on our strategy to develop and deliver retinal treatments through our Zimura, gene therapy and HtrA1 inhibitor programs, with the potential to create long-term shareholder value."

Age-Related Macular Degeneration Programs

Zimura (avacincaptad pegol): Complement C5 Inhibitor
•In June 2020, the Company announced positive 18 month results from GATHER1, its first Phase 3 clinical trial for Zimura, a novel complement C5 inhibitor, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The 18 month data supports the previously announced 12 month data from this trial, at which time point Zimura met the pre-specified primary efficacy endpoint with statistical significance. Zimura was generally well tolerated after 18 months of administration.

•The GATHER1 data was presented at The Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, May 3 – 7, 2020 by Karl G. Csaky, MD, T. Boone Pickens Senior Scientist and Director of the Molecular Ophthalmology Laboratory at the Retina Foundation of the Southwest, and was also presented at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting, July 24 – 26, 2020 by Baruch D. Kuppermann, MD, Chairman of the Department of Ophthalmology at UC Irvine.

•In late June 2020, the Company announced that the first patient had been dosed in GATHER2, its second Phase 3 clinical trial for Zimura in development for the treatment of GA secondary to AMD. If 12 month

results from GATHER2 are positive, the Company plans to file an application with the U.S. Food and Drug Administration and the European Medicines Agency for marketing approval of Zimura for GA.

•In April 2020, the U.S. FDA granted Fast Track designation for Zimura for the treatment of GA secondary to AMD. Fast Track designation offers important benefits, including frequent interactions with the FDA and the potential eligibility for rolling submission and priority review of a New Drug Application, if relevant criteria are met.

•The Company increased the enrollment target in its ongoing Phase 2b screening clinical trial of Zimura for the treatment of autosomal recessive Stargardt disease. After initially enrolling 95 patients in this trial, the Company plans to enroll approximately 25 additional patients, with the goal of enrolling a total of 120 patients as was initially intended in the protocol for this trial.

IC-500: HtrA1 (high temperature requirement A serine peptidase 1 protein) Inhibitor
•The Company selected a lead product candidate from its HtrA1 inhibitor program, which it will refer to as IC-500. Based on current timelines, the Company is planning to submit an IND with the U.S. FDA for IC-500 in GA secondary to AMD in 2021.

Gene Therapy Programs in Orphan Inherited Retinal Diseases (IRDs)

•IC-100: Rhodopsin-Mediated Autosomal Dominant Retinitis Pigmentosa (RHO-adRP) and IC-200: BEST1-Related IRDs
Natural history studies and IND-enabling activities for IC-100 and IC-200 are ongoing. The Company plans to begin enrolling patients in Phase 1/2 clinical trials for IC-100 during the first half of 2021 and for IC-200 in 2021.

•Minigene Programs
The Company, in collaboration with the University of Massachusetts Medical School, continues to advance its minigene program for Leber Congenital Amaurosis Type 10 (LCA10), autosomal recessive Stargardt Disease (ABCA4), and USH2A-related IRDs. The Company expects to select a lead construct for its LCA10 minigene program and obtain additional results for its Stargardt Disease minigene program by the end of 2020. The Company expects to obtain preliminary results from its USH2A minigene program in late 2020 or early 2021.

Corporate Update
In April 2020, the Company appointed Pravin U. Dugel, MD as Executive Vice President and Chief Strategy and Business Officer. In July 2020, Mark S. Blumenkranz, MD, MMS, joined its board of directors.

Second Quarter 2020 Operational Update and Cash Guidance
As of June 30, 2020, the Company had $245.7 million in cash and cash equivalents. In June 2020, the Company raised approximately $150 million in net proceeds in an underwritten public offering of common stock, and pre-funded warrants in lieu of common stock, and a concurrent private placement of common stock. The Company now estimates that its year-end 2020 cash and cash equivalents will range between $215 million and $220 million. The Company also estimates that its cash and cash equivalents will be sufficient to fund its currently planned capital expenditure requirements and operating expenses, excluding any potential approval or sales milestones payable to Archemix Corp. or any commercialization expenses for Zimura, through at least mid-2024. These estimates are based on the Company’s current business plan, which includes the continuation of the Company’s clinical development programs for Zimura, the progression of the Company’s IC-100 and IC-200 programs into the clinic, and the advancement of the Company’s IC-500 development program. These estimates assume that the Company will enroll approximately 400 patients in the GATHER2 trial. These estimates do not reflect any additional expenditures resulting from the potential in-licensing or acquisition of additional product candidates or technologies, commencement of any new sponsored research programs, or any associated develop that the Company may pursue.

2020 Q2 Financial Highlights

•R&D Expenses: Research and development expenses were $12.7 million for the quarter ended June 30, 2020, compared to $10.0 million for the same period in 2019. For the six months ended June 30, 2020, research and development expenses were $26.5 million compared to $17.7 million for the same period in 2019. Research and development expenses increased primarily due to increased manufacturing and preclinical development costs associated with the Company’s IC-100 and IC-200 gene therapy programs, the initiation and start-up activities for its GATHER2 clinical trial, manufacturing activities for Zimura and the progression of its HtrA1 inhibitor program.

•G&A Expenses: General and administrative expenses were $6.3 million for the quarter ended June 30, 2020, compared to $5.2 million for the same period in 2019. For the six months ended June 30, 2020, general and administrative expenses were $11.3 million compared to $10.7 million for the same period in 2019. General and administration expenses increased primarily due to increases in professional fees and general consulting costs.

•Income Tax (Benefit): Income tax benefits of $0.4 million and $3.7 million for the three and six months ended June 30, 2020, respectively, were recognized to reflect a favorable settlement of a state corporate income tax audit.

•Net Income: The Company reported a net loss for the quarter ended June 30, 2020 of $18.6 million, or ($0.32) per diluted share, compared to a net loss of $14.4 million, or ($0.35) per diluted share, for the same period in 2019. For the six months ended June 30, 2020, the Company reported a net loss of $33.7 million or ($0.61) per diluted share, compared to a net loss of $26.9 million or ($0.65) for the same period in 2019.

Conference Call/Web Cast Information
IVERIC bio will host a conference call/webcast to discuss the Company’s financial and operating results and provide a business update. The call is scheduled for August 5, 2020 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 888-220-8451 (USA) or 323-794-2588 (International), passcode 2738321. A live, listen-only audio webcast of the conference call can be accessed on the Investors section of the IVERIC bio website at www.ivericbio.com. A replay will be available approximately two hours following the live call for two weeks. The replay number is 888-203-1112 (USA), passcode 2738321.

On August 5, 2020 Horizon Therapeutics plc (Nasdaq: HZNP) reported record second-quarter 2020 financial results (Press release, Horizon Pharma, AUG 5, 2020, View Source [SID1234562871]). The Company increased its full-year 2020 net sales and adjusted EBITDA guidance on continued strength of TEPEZZA. In addition to increasing TEPEZZA full-year 2020 net sales guidance, the Company also increased its peak U.S. annual net sales estimate for the medicine.

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!

"Driving our record second-quarter performance was the continued tremendous patient and physician response to TEPEZZA, along with our outstanding commercial execution, making the TEPEZZA launch one of the most successful rare disease medicine launches ever, despite a challenging COVID-19 environment," said Tim Walbert, chairman, president and chief executive officer, Horizon. "With TEPEZZA results having once again dramatically exceeded expectations, we increased both our TEPEZZA and Company full-year net sales guidance, as well as increased our TEPEZZA peak U.S. annual net sales estimate. We also continued to advance our clinical programs and improve our capital structure during the quarter. With our strong track record of strategic execution and driving value for patients and shareholders alike, Horizon is well positioned for long-term growth and success."

Second-Quarter and Recent Company Highlights

Strong Commercial Launch Drives Increase of TEPEZZA Peak U.S. Annual Net Sales Estimate: Today, the Company increased its peak U.S. annual net sales estimate for TEPEZZA to greater than $3 billion from the previous estimate of greater than $1 billion, as well as increased full-year 2020 net sales guidance to greater than $650 million from greater than $200 million. Several factors have contributed to the increased expectations, including the severity of TED, which is a motivating factor for patients seeking treatment; the Company’s market education efforts to increase awareness of TED, develop the market and assist with patient access; and a high volume of patient and physician interest driven by the Company’s commercial execution.

Announced Topline Data from TEPEZZA OPTIC-X Open-Label Extension Trial and OPTIC 48-Week Off-Treatment Follow-Up Period: In July 2020, the Company announced new topline results from its OPTIC-X open-label clinical trial, an extension trial of OPTIC, the TEPEZZA Phase 3 pivotal confirmatory clinical trial, as well as data from the OPTIC 48-week off-treatment follow-up period. OPTIC-X results demonstrate that 89 percent of patients who received placebo during OPTIC and then entered OPTIC-X and received TEPEZZA achieved the primary endpoint of 2 mm or more reduction in proptosis at Week 24. These patients had TED diagnosis for an average of one year compared with an average of six months in OPTIC. The results of the OPTIC 48-week off-treatment follow-up period demonstrated that the majority of TEPEZZA patients who were proptosis responders at Week 24 of OPTIC maintained their response at Week 72, nearly a year off treatment. For the small number of TEPEZZA patients who relapsed during the OPTIC follow-up period, the majority experienced improvements in proptosis with an additional course of TEPEZZA in OPTIC-X.

Reached Target Enrollment for KRYSTEXXA MIRROR RCT: In July 2020, the Company announced that the MIRROR RCT, the first randomized trial to evaluate the efficacy and safety of the concomitant use of KRYSTEXXA with methotrexate to increase the duration of response of KRYSTEXXA, reached its target enrollment of 135 patients. Preliminary results are expected in the first half of 2021.

New KRYSTEXXA Immunomodulation Data Presented: A series of data on KRYSTEXXA co-prescribed with commonly used immunomodulators, including methotrexate, leflunomide, mycophenolate mofetil and azathioprine, were presented virtually at the 2020 European League Against Rheumatism (EULAR) congress in June. The presentations showed response rates for KRYSTEXXA with immunomodulators ranging between 70 and 100 percent. The response rate of the KRYSTEXXA Phase 3 trials was 42 percent. The presentations added to the growing body of evidence supporting the immunomodulation treatment approach.

Expanded the Company’s Pipeline with Acquisition of Development-Stage Candidate HZN-825: On April 1, 2020, the Company completed the acquisition of Curzion Pharmaceuticals, Inc. and its lysophosphatidic acid 1 receptor (LPAR1) antagonist candidate (renamed HZN-825) for the treatment of diffuse cutaneous systemic sclerosis (dcSSc).

Permanent J-Code Issued for TEPEZZA: In July 2020, the Company announced that the U.S. Centers for Medicare and Medicaid Services (CMS) assigned a permanent, product-specific Healthcare Common Procedure Coding System (HCPCS) J-code (J3241) for TEPEZZA. The permanent J-code, which enables reimbursement in all outpatient treatment settings, is expected to go into effect on Oct. 1, 2020.

Acquired Certain Rights to Proceeds from Future Milestones and Royalties Related to TEPEZZA: In April 2020, in two separate transactions, the Company acquired the rights to proceeds from certain contingent future milestones and royalties related to TEPEZZA net sales in exchange for an aggregate payment of $110 million. These transactions relate to the rights to approximately 71 percent of the $225 million in milestone payments due upon achievement of certain TEPEZZA annual worldwide net sales thresholds and approximately 71 percent of the 3 percent royalty tied to the portion of TEPEZZA annual worldwide net sales exceeding $300 million.

Further Improved the Company’s Capital Structure: On Aug. 3, 2020, the Company completed the extinguishment of all $400 million of its 2.50 percent exchangeable senior notes due 2022. Since the beginning of 2019, the Company has reduced its gross debt by approximately $1 billion, while maintaining a strong cash balance. In part as a result of the extinguishment, S&P revised its outlook on the Company to positive from stable.

Announced Expanded Commercial Leadership Structure: As Horizon continues to grow at a rapid pace, it is expanding its leadership structure to separate the geographic oversight of its commercial operations to prepare for long-term global expansion. Vikram Karnani will now oversee international operations as executive vice president and president, International and Daniel A. Camardo will now oversee U.S. operations as executive vice president and president, U.S.

Received Best Workplace Awards: In April 2020, Great Place to Work and Fortune selected Horizon as one of the 2020 "Best Workplaces in Health Care and Biopharma" for the third consecutive year and Great Place to Work also named Horizon as the No. 1 "Best Workplace in Chicago" in the small and medium category.

Key Research and Development Programs

HZN-825 dcSSc Program: HZN-825 is the Company’s LPAR1 antagonist in development for the treatment of dcSSc, a rare, chronic autoimmune disease marked by fibrosis, or skin thickening, with no FDA-approved treatment options. The Company expects to begin a Phase 2b pivotal trial in the first half of 2021.

TEPEZZA Trial in Chronic (Inactive) TED: The Company expects to initiate a trial of TEPEZZA in patients with chronic TED (previously referred to as inactive TED) by year-end 2020. In chronic TED, the disease is no longer progressive; however, significant disease manifestations such as proptosis (eye bulging) and diplopia (double vision) remain.

Potential TEPEZZA Subcutaneous Administration Program: The Company is planning to initiate a pharmacokinetic trial later this year to explore subcutaneous dosing of TEPEZZA, which is currently administered by infusion. The objective of the trial is to inform the potential for additional administration options for TEPEZZA, which could provide greater flexibility for patients and physicians.

TEPEZZA dcSSc Exploratory Trial: As part of its evaluation of additional indications for TEPEZZA, the Company is planning to initiate an exploratory trial in dcSSc by the end of 2020.

KRYSTEXXA MIRROR RCT: The Company is currently evaluating the efficacy and safety of the concomitant use of KRYSTEXXA with methotrexate to increase the complete response rate of KRYSTEXXA in the MIRROR placebo-controlled RCT. In July 2020, MIRROR RCT reached its target enrollment of 135 patients, and additional patients in screening will also randomize if eligible. The registrational trial is designed to enable the potential submission of results to the FDA to update the prescribing information. The MIRROR RCT follows the MIRROR open-label trial completed in 2019 that demonstrated a 79 percent complete response rate for patients using KRYSTEXXA with methotrexate, nearly double the 42 percent response rate in the KRYSTEXXA Phase 3 clinical program, which evaluated KRYSTEXXA alone. Methotrexate is the immunomodulator most used by rheumatologists and has been shown to reduce anti-drug antibody formation to biologic therapies when used in conjunction with these therapies.

KRYSTEXXA PROTECT Trial in Kidney Transplant Patients with Uncontrolled Gout: The Company has achieved more than 50 percent enrollment in its PROTECT open-label clinical trial, and expects to complete enrollment by the end of 2020. The trial is evaluating the effect of KRYSTEXXA on serum uric acid levels in kidney transplant patients with uncontrolled gout. Kidney transplant patients have more than a tenfold increase in the prevalence of gout when compared to the general population, and literature suggests that persistently high serum uric acid levels can be associated with organ rejection. Managing uncontrolled gout is one of the most common and significant unmet needs of kidney transplant patients.

KRYSTEXXA Shorter-Infusion Duration Trial: The Company expects to initiate an open-label trial by the end of 2020 to evaluate the impact of administering KRYSTEXXA over a significantly shorter infusion duration. Currently, KRYSTEXXA is infused over a two-hour or longer timeframe. A shorter infusion duration could meaningfully improve the experience and convenience for patients, physicians and sites of care.

Second-Quarter Financial Results

Note: For additional detail and reconciliation of non-GAAP financial measures to the most directly comparable GAAP financial measures, please refer to the tables at the end of this release.

Net Sales: Second-quarter 2020 net sales were $462.8 million, an increase of 44 percent.

Gross Profit: Under U.S. GAAP, the second-quarter 2020 gross profit ratio was 73.7 percent compared to 72.2 percent in the second quarter of 2019. The non-GAAP gross profit ratio in the second quarter of 2020 was 88.4 percent compared to 90.9 percent in the second quarter of 2019.

Operating Expenses: Research and development (R&D) expenses were 17.5 percent of net sales and selling, general and administrative (SG&A) expenses were 48.0 percent of net sales. Non-GAAP R&D expenses were 6.1 percent of net sales, and non-GAAP SG&A expenses were 41.4 percent of net sales.

Income Tax Expense: In the second quarter of 2020, income tax expense on a GAAP and non-GAAP basis was $83.0 million and $93.6 million, respectively.

Net (Loss) Income: On a GAAP basis in the second quarter of 2020, net loss was $80.0 million. Second-quarter 2020 non-GAAP net income was $83.8 million.

Adjusted EBITDA: Second-quarter 2020 adjusted EBITDA was $190.7 million.

(Loss) Earnings per Share: On a GAAP basis diluted loss per share in the second quarter of 2020 and 2019 was $0.42 and $0.03, respectively. Non-GAAP diluted earnings per share in the second quarter of 2020 and 2019 was $0.40 and $0.49, respectively. Weighted average shares outstanding used for calculating GAAP and non-GAAP diluted earnings per share in the second quarter of 2020 were 192.7 million and 214.5 million, respectively.

Second-Quarter Segment Results

Management uses net sales and segment operating income to evaluate the performance of the Company’s two segments, the orphan segment and the inflammation segment. While segment operating income contains certain adjustments to the directly comparable GAAP figures in the Company’s consolidated financial results, it is considered to be prepared in accordance with GAAP for purposes of presenting the Company’s segment operating results.

On August 5, 2020 EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing innovative ophthalmic products, reported financial results for the second quarter ended June 30, 2020 and highlighted recent corporate developments (Press release, pSivida, AUG 5, 2020, View Source [SID1234562870]).

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 were encouraged by the re-opening of healthcare facilities in select regions of the U.S during the quarter-end as underlying customer demand from our distributors was strong in June for both YUTIQ and DEXYCU. We believe the distinct advantages of single-injection, long-lasting activity provides for fewer office visits and less contact with patient eyes and positions both products for expanded use during the COVID-19 pandemic and recovery," said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. "We are also very excited to announce our new U.S. commercial alliance with ImprimisRx for DEXYCU and believe that this collaboration will significantly enhance the DEXYCU opportunity by reaching new physicians and ambulatory surgery centers, while also pairing DEXYCU with Harrow’s complementary ophthalmology drug offerings. In addition to increased physician reach, this agreement keeps our commercial cost structure at our previously announced reduced levels. As we continue to further build our commercial efforts and product education initiatives, we remain very focused on our balance sheet and continue to actively manage our spending burn rate as we look to extend our cash runway into 2021."

Ms. Lurker continued, "Our new Chief Strategic Scientific Officer, Dr. Jay Duker, will lead our development efforts for EYP-1901, a potential six-month sustained delivery anti-VEGF therapy using our bioerodible Durasert technology. The good laboratory practice (GLP) toxicology study for this program is progressing well and we expect data in the coming months to support filing of

an Investigational New Drug (IND) application in the fourth quarter. We are very excited to advance this program to potentially treat wet age-related macular degeneration (wet AMD), a significant market in need of innovative, long-lasting therapies."

Commercial Performance in Second Quarter 2020

During the quarter, public health authorities and government agencies, including the Centers for Medicare & Medicaid Services (CMS), issued recommendations for the re-opening of health care systems and the resumption of non-essential elective surgeries, including cataract surgery, in areas with low or stable incidence of COVID-19.

As a result, office visits for uveitis and retinal specialists increased and ambulatory surgery centers (ASCs) resumed operations and scheduling of surgeries in select U.S. regions on a limited basis.

Customer demand for YUTIQ, represented as units purchased by physicians from the Company’s distributors, was 428 units in Q2 as compared to 537 units in Q1. June represented 167 units of that demand.

Customer demand for DEXYCU, represented as units purchased by ASCs from the Company’s distributors, was 2,096 units in Q2 as compared to 3,462 units in Q1. June represented one of the highest customer demand months of 2020 for DEXYCU, with 1,592 units, despite reductions in our commercial organization that were announced on April 1.

The Company continues to actively monitor the COVID-19 pandemic and associated public health recommendations to ensure the safety of our patients and physicians as regions of the U.S. begin to reopen.

Operations Update

In August, the Company announced a U.S. commercial alliance with ImprimisRx, the nation’s leading ophthalmic-focused outsourcing facility, for DEXYCU, in which it will be marketed as prioritized product. Under the terms of the commercial alliance, ImprimisRx will deploy its sales team to immediately begin promoting DEXYCU to its accounts with an initial focus on accounts currently purchasing Tri-Moxi for ocular surgery inflammation. EyePoint will be responsible for the marketing, selling, pricing, manufacturing, and contracting for DEXYCU while also seeking additional volume-based agreements with ASCs and integrated health care networks to expand patient access. ImprimisRx will be entitled to receive a commission on the incremental sales that exceed pre-specified baselines.

In July, Jay S. Duker, M.D, was appointed to the newly created role of Chief Strategic Scientific Officer. Dr. Duker will lead the strategic advancement of research and development efforts, beginning with our lead development candidate, EYP-1901, for wet AMD and new pipeline expansion opportunities under evaluation. Dr. Duker is world renowned retinal disease expert and serves as the Director of the New England Eye Center. and Professor and Chair of Ophthalmology at Tufts Medical Center and Tufts University School of Medicine.

R&D Highlights

In July, data from the first Phase 3 trial of YUTIQ were presented at the American Society of Retina Specialists Virtual Annual Meeting. A post-hoc analysis of imputed recurrences revealed over half were from confounding systemic medication use, which suggest the recurrence rate for YUTIQ is likely lower than the reported 56% at 36-months. The results

also demonstrated YUTIQ increased the resolution of macular edema and improved visual acuity at 36-months.

In June, supportive data from the Phase 2 trial of orally delivered vorolanib, the anri-VEGF molecule in EYP-1901, conducted by Tyrogenex, Inc. for the treatment of wet AMD were published in the British Journal of Ophthalmology. Oral voloranib demonstrated non-inferiority in visual acuity compared to placebo with best corrected visual acuity (BCVA) stable through 12-months. The three oral vorolanib doses levels studied also demonstrated a decreased intravitreal anti-VEGF injection burden and a longer time to first treatment as compared to placebo. There were several instances in which patients on voloranoib did not require another anti-VEGF injection after screening. The trial was prematurely stopped due to gastrointestinal and hepatobiliary toxicity concerns. The efficacy results provide additional validation of vorolanib for use in EYP-1901 as a potential single dose sustained release treatment for wet AMD.

In June, a post-hoc analysis of cases of bilateral uveitis in the first Phase 3 trial of YUTIQ were presented virtually at the Association for Research in Vision and Ophthalmology Annual Meeting. Outcomes for the untreated fellow eye were examined as a means of understanding the natural history of the disease and showed a recurrence rate of 86.4% compared to 56.3% for YUTIQ treated eyes at 36-months. At 36-months, fellow eyes also showed a higher rate of the need for the assistance of adjunctive intraocular/periocular injection medication for uveitic inflammation, more macular edema, and a one-line average decrease in BCVA. These supportive results reinforce the long-term, anti-inflammatory activity of YUTIQ for this difficult to treat disease.

In May, four abstracts highlighting data from the ongoing retrospective study of real-world use of DEXYCU were presented at the American Society of Cataract and Refractive Surgery 2020 Virtual Annual Meeting. The data showed DEXYCU’s early-acting anti-inflammatory activity resulted in complete anterior chamber cell clearing (cell score=0), a measurement of inflammation, in 51.2%, 60.9%, 86.2% and 90.5% at postoperative day 1, 8, 14 and 30, respectively. The proportion of patients with no anterior chamber flares (flare score=0), another measurement of inflammation, was 85.9%, 97.1%, 99.1% and 99.1% at postoperative day 1, 8, 14 and 30, respectively. DEXYCU also received high marks on the physician survey of product satisfaction, ease of use, efficacy compared to topic steroids and patient satisfaction.

Review of Second Quarter Results Ended June 30, 2020

For the three months ended June 30, 2020, total net revenue was $4.1 million compared to $7.2 million for the three months ended June 30, 2019. Net product revenue for the three months ended June 30, 2020 was $3.7 million, with $2.9 million for YUTIQ and $0.8 million for DEXYCU, compared to net product revenue for three months ended June 30, 2019 of $6.7 million generated by YUTIQ. Net product revenue represents product purchased by EyePoint’s distributors whereas customer demand represents purchases of product by physician practices and ambulatory surgery centers from EyePoint’s distributors.

Net revenue from royalties and collaborations for the three months ended June 30, 2020 totaled $416,000 compared to $505,000 in the corresponding quarter in 2019.

Operating expenses for the three months ended June 30, 2020 decreased to $15.3 million from $17.4 million in the prior year period, due primarily to decreased sales and marketing costs from our previously announced restructuring as well as lower research and development costs. Non-

operating expense, net, for the three months ended June 30, 2020 totaled $1.8 million of net interest expense. Net loss for the three months ended June 30, 2020 was $13.0 million, or $0.10 per share, compared to a net loss of $11.5 million, or $0.11 per share, for the prior year quarter.

Review of Six Months Results Ended June 30, 2020

For the six months ended June 30, 2020, total revenue was $11.6 million compared to $9.2 million for the six months ended June 30, 2019. Net product revenue for the six months ended June 30, 2020 was $8.4 million, compared to net product revenue for six months ended June 30, 2019 of $7.9 million.

Net revenue from royalties and collaborations for the six months ended June 30, 2020 totaled $3.2 million compared to $1.3 million in the corresponding quarter in 2019.

Operating expenses for the six months ended June 30, 2020 totaled $34.2 million from $34.0 million in the prior year period. This increase was primarily from higher cost of sales due to higher product sales as well as an increased royalty expense stemming from a $2 million upfront payment received during Q1-2020 for the licensing of DEXYCU in China.

Non-operating expense, net, for the six months ended June 30, 2020 totaled $3.5 million. Net loss for the six months ended June 30, 2020 was $26.1 million, or $0.22 per share, compared to a net loss of $30.7 million, or $0.30 per share, for the prior year period.

Cash and cash equivalents at June 30, 2020 totaled $22.8 million compared to $22.2 million at December 31, 2019.

Financial Outlook

We expect that the Company’s cash and cash equivalents combined with projected cash inflows from anticipated YUTIQ and DEXYCU product sales and other expected financing activities can fund the Company’s operating plan into 2021 under current assumptions for the duration of the COVID-19-related closures across the U.S.

The Company continues to assess additional cash conservation and generation measures to support its operations through the COVID-19 pandemic.

Conference Call Information

EyePoint will host a conference call today, Wednesday, August 5, 2020, at 8:30 AM ET to discuss the results for the first quarter ended March 31 and recent operational developments. To access the conference call, please dial (877) 312-7507 from the U.S. and Canada or (631) 813-4828 (international) at least 10 minutes prior to the start time and refer to conference ID 5815799. A live webcast will be available on the Investor Relations section of the corporate website at View Source A replay of the webcast will also be available on the corporate website.