Aduro Biotech Provides Business Update and Reports First Quarter 2020 Financial Results

On May 4, 2020 Aduro Biotech, Inc. (NASDAQ: ADRO), a clinical-stage biopharmaceutical company focused on developing therapies targeting the Stimulator of Interferon Genes (STING) and A Proliferation Inducing Ligand (APRIL) pathways for the treatment of cancer, autoimmune and inflammatory diseases, reported financial results for the first quarter ended March 31, 2020 (Press release, Aduro Biotech, MAY 4, 2020, View Source [SID1234556962]).

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"We ended the first quarter of 2020 with a cash position of $205.9 million, which enables us to continue supporting the development of our STING and APRIL programs into 2023. We are currently focused on activating clinical trial sites and enrolling patients for Part 3 of our Phase 1 study of BION-1301 in IgA nephropathy and driving enrollment of patients in our Phase 2 study of ADU-S100 in combination with pembrolizumab in squamous cell carcinoma of the head and neck (SCCHN)," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "Despite the challenges associated with the current COVID-19 pandemic, our Board and leadership team remain committed to supporting the safety of our employees while moving our STING and APRIL clinical programs forward."

Recent Highlights

Announced corporate restructuring to reduce operating expenses and extend cash runway into 2023.

Received a $10 million development milestone payment from license partner, Merck & Co., Inc. (known as MSD outside the United States and Canada) (Merck). The payment was received as a result of Merck’s initiation of a Phase 2 clinical trial of MK-5890, the anti-CD27 agonist antibody licensed to Merck in 2014, in patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC) that have been previously treated with anti-PD-L1 therapy.

Announced an update on clinical trial timelines and business operations in light of the COVID-19 global pandemic.

We expect delays in activating additional sites and enrolling patients into Part 3 of the Phase 1 clinical trial of BION-1301 in IgA nephropathy. As a result, our ability to report data in IgA nephropathy patients will likely be delayed until the first half of 2021.

Despite some delays in additional site activation and patient enrollment and anticipated delays in patient follow-up and data analysis, we expect to present interim data for the ongoing Phase 2 clinical trial evaluating ADU-S100 and pembrolizumab in SCCHN in the second half of 2020.

We are continuing preparations to initiate a Phase 1 clinical trial evaluating ADU-S100 as an intravesical monotherapy for non-muscle invasive bladder cancer in the second half of 2020. However, study start-up activities may be delayed.

Financial Results

Cash Position – Cash, cash equivalents and marketable securities totaled $205.9 million at March 31, 2020, compared to $213.6 million at December 31, 2019.

Revenue – Revenue was $14.0 million for the first quarter of 2020 compared to $3.9 million for the same period in 2019. The increase in revenue for the quarter was primarily due to recognition of the $10.0 million development milestone payment received under our license and research agreement with Merck.

Expenses –

Research and development expenses were $15.8 million for the first quarter of 2020 compared to $17.5 million for the same period in 2019. The quarter to date costs decreased primarily due to lower costs related to our programs that are winding down partially offset by higher costs as a result of focused spending towards our STING and APRIL programs. The decrease was also attributable to lower compensation and related personnel costs as well as stock-based compensation as compared to 2019.

General and administrative expenses were $7.8 million for the first quarter of 2020 compared to $8.2 million for the same period in 2019. The quarter to date costs decreased primarily due to lower personnel and stock-based compensation expense, as compared to 2019.

Restructuring and related expense was $4.3 million for the first quarter of 2020 compared to $3.0 million for the same period in 2019. The 2020 restructuring and related expenses consisted of severance and employee retention costs as well as the impairment of property and equipment associated with the planned closure of the Oss facility as part of the January 2020 restructuring plan. The $3.0 million restructuring and related expense recorded in 2019, which includes employee severance and retention payments, related to the January 2019 strategic reset.

Net Loss – Net loss for the first quarter of 2020 was $7.6 million or $0.09 per share compared to net loss of $23.4 million or $0.29 per share for the same period in 2019. In addition to the factors described above, the net loss was offset by approximately $5.7 million of income tax benefit related to an income tax refund resulting from the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The income tax refund is expected to be received in the second half of 2020.

Varian Reports Results for Second Quarter of Fiscal Year 2020; Withdraws 2020 Guidance

On May 4, 2020 Varian (NYSE: VAR) reported its second quarter fiscal year 2020 results (Press release, Varian Medical Systems, MAY 4, 2020, View Source [SID1234556961]).

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"On behalf of everyone at Varian, I want to express our gratitude to all individuals on the frontlines dedicated to fighting this global pandemic. I also want to thank Varian employees worldwide who continue to focus on cancer patients receiving vital care during these turbulent times," said Dow Wilson, Chief Executive Officer of Varian. "While COVID-19 has created some unique challenges, our business has solid liquidity and is well-positioned strategically and organizationally to navigate through this challenging environment, continue to grow our market leadership, and deliver best-in-class solutions to cancer patients globally."

Non-GAAP net earnings and non-GAAP net earnings per diluted share are defined as GAAP net earnings and GAAP net earnings per diluted share adjusted to exclude the amortization of intangible assets and amortization of inventory step-up, acquisition and integration-related expenses or benefits, impairment charges, significant litigation charges or benefits, legal costs, gains and losses on equity investments, and significant non-recurring tax expense or benefits. Reconciliation of GAAP and non-GAAP financial measures can be found at the end of the press release.

The company ended the quarter with $668 million in cash and cash equivalents and $521 million in debt. Net cash provided by operating activities was $22 million. During the quarter, the company invested $40 million to repurchase three hundred and fifteen thousand shares of common stock.

Impact of COVID-19 Pandemic
The impact of the pandemic in the quarter has varied by region based on the stage of containment and government actions. The impact on revenues in the quarter was primarily due to timing delays associated with installations and acceptance of the company’s products and solutions, as well as delays in the delivery of interventional oncology procedures. As shared in the March 9 press release, the preliminary impact from COVID-19 for the fiscal second quarter was limited to the Asia-Pacific geography. Between March 9 and the end of the quarter, the pandemic spread and impacted the company’s operating performance in the Americas and EMEA (Europe, Middle East, India, and Africa) geographies. The company estimates the operational delays after March 9 negatively impacted revenues in those two geographies by approximately $30 million. This was partially offset by better performance across Asia-Pacific during the last three weeks of the quarter as China and South Korea began to recover from the pandemic.

Oncology Systems Segment
Oncology Systems revenues totaled $761 million, up 2%. GAAP operating earnings were $111 million, down 16%. Gross orders were $773 million, up 1%. Gross orders in the Americas were down 3%, including North America down 1%. In EMEA, gross orders rose 11% driven by two large orders, in Russia and the United Kingdom. In Asia-Pacific, gross orders were down 5%. Gross orders globally were impacted by delays related to COVID-19.

Proton Solutions Segment
The company received two new system orders in Asia-Pacific in the quarter. Proton Solutions revenues totaled $22 million, down 32%. Operating earnings benefited from higher service revenues which were offset by project mix.

Other Segment
Revenues for the Other segment were $12 million. The Other segment is comprised of the Interventional Solutions business, including cryoablation, embolic microspheres, and microwave ablation. Additionally, it includes investments in cardiac radioablation.

Non-GAAP Adjustments
GAAP operating earnings and GAAP EPS included a $41 million impairment of loan receivables from California Proton Therapy Center and a $9 million benefit from the reversal of acquisition-related earnouts.

Guidance Withdrawn for Full Fiscal Year 2020
Since the previous update provided by the company on March 9, 2020, the severity of the COVID-19 pandemic has expanded globally and resulted in a shift in the macroeconomic environment. The uncertainty around the severity and duration of COVID-19 has impacted the company’s ability to reliably estimate the financial impact of the pandemic for the balance of the fiscal year. As a result, the company is withdrawing its fiscal year 2020 guidance. Additionally, as a precautionary measure, the company has paused share buybacks to preserve liquidity.

Investor Conference Call
Varian Medical Systems is scheduled to conduct its second quarter fiscal year 2020 conference call at 1:30 p.m. Pacific Time today. To access the live webcast or replay of the call, visit the Investor Relations page on the company’s website at www.varian.com/investors. To access the call via telephone, dial 1-877-869-3847 from inside the U.S. or 1-201-689-8261 from outside the U.S. The replay can be accessed by dialing 1-877-660-6853 from inside the U.S. or 1-201-612-7415 from outside the U.S. and entering conference ID 13700412. The teleconference replay will be available until 5:00 p.m. Pacific Time, Friday, May 8, 2020.

Kura Oncology Reports First Quarter 2020 Financial Results

On May 4, 2020 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported first quarter 2020 financial results and provided a corporate update (Press release, Kura Oncology, MAY 4, 2020, View Source [SID1234556960]).

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"We recently completed a strategic review of our portfolio with the goal of prioritizing programs that have the highest potential to create value," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "As a result, we intend to enhance our focus on two major pillars of the company: our farnesyl transferase inhibitor, tipifarnib, for HRAS-dependent head and neck squamous cell carcinoma (HNSCC), including HRAS mutant and HRAS overexpressed HNSCC, as well as our menin inhibitor, KO-539, for NPM1-mutant and KMT2A(MLL)-rearranged acute myeloid leukemia (AML). This sharpened focus will enhance our efforts around each of these important programs and help to ensure that we are in a strong cash position as we navigate the challenges of the COVID-19 pandemic and continue to advance toward potential value inflection points."

Corporate Update

Prioritized development of menin inhibitor, KO-539 – KO-539 is a potent and selective small molecule inhibitor of the menin-KMT2A(MLL) protein-protein interaction with the potential to target approximately 35% of all AML. A Phase 1/2A clinical trial of KO-539 in relapsed/refractory AML, named KOMET-001, continues in dose escalation. Based on its encouraging progress in the clinic and its potential to create significant value, Kura has prioritized the development of KO-539 in NPM1-mutant and KMT2A/MLL-rearranged AML.

Three tipifarnib abstracts accepted for presentation at ASCO (Free ASCO Whitepaper) – Three abstracts highlighting data from tipifarnib in HRAS mutant solid tumors have been accepted for presentation, including an oral presentation featuring matured clinical outcome data from the Phase 2 clinical trial of tipifarnib in HRAS mutant HNSCC, at the upcoming 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program.

Expanding enrollment of AIM-HN registration-directed trial of tipifarnib in HRAS mutant HNSCC – Based on the Phase 2 dataset and feedback from treating physicians, Kura intends to amend its AIM-HN registration-directed trial to enroll all HRAS mutant HNSCC patients regardless of variant allele frequency and in doing so expand the proportion of HRAS mutant HNSCC patients who are being treated and may ultimately benefit from tipifarnib. The AIM-HN trial will continue to enroll patients while the amendment is being implemented, and the Company plans to communicate more specifics regarding the amendment following the data presentation at ASCO (Free ASCO Whitepaper). Given the proposed amendment and the ongoing impact of COVID-19 on screening and enrollment for this trial, the Company is suspending guidance on full enrollment in the AIM-HN trial until it has more clarity on timing.

HRAS overexpressing HNSCC represents a significant expansion opportunity for tipifarnib – In addition to pursuing the first registrational opportunity in recurrent or metastatic HRAS mutant HNSCC, Kura has also generated encouraging preclinical data showing the potential for tipifarnib in patients with HNSCC whose tumors overexpress the HRAS gene. It is estimated that up to 20% of HNSCC patients have tumors that overexpress HRAS, which can drive resistance to other therapies. Based upon the unmet need and its preclinical data, Kura intends to pursue the clinical development of tipifarnib in combination with other therapies as a strategy to treat HRAS overexpressing HNSCC patients.

Orphan drug designation for tipifarnib in T-cell lymphoma – Last month, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to tipifarnib for the treatment of T-cell lymphoma, recognizing its potential to address a high unmet need for these patients. Although Kura continues to believe that CXCL12 pathway biomarkers have potential to unlock the therapeutic value of farnesyl transferase inhibitors across a range of hematologic and solid tumor indications, due to the challenges associated with the COVID-19 global pandemic, the Company is pausing the initiation of both its proposed registration-directed trial of tipifarnib in T-cell lymphoma and its proof-of-concept study of tipifarnib in pancreatic cancer. The Company intends to use this time to explore strategies to further optimize these opportunities for future development.

Terminating development of ERK inhibitor, KO-947 – Earlier this year, Kura’s Phase 1 trial of KO-947 was placed on a partial clinical hold due to a dose-limiting adverse drug reaction in a single patient on study. Although the Company was successful in lifting the partial clinical hold and continues to have an interest in 11q13-amplified solid tumors, Kura has opted to terminate further development of KO-947 in order to focus its resources on programs with the highest potential to benefit patients and create value.
Financial Results

Research and development expenses for the first quarter of 2020 were $12.6 million, compared to $10.4 million for the first quarter of 2019.

General and administrative expenses for the first quarter of 2020 were $7.6 million, compared to $4.6 million for the first quarter of 2019.

Net loss for the first quarter of 2020 was $19.2 million, compared to a net loss of $13.9 million for the first quarter of 2019.

Cash, cash equivalents and short-term investments totaled $216.9 million as of March 31, 2020, compared with $236.9 million as of December 31, 2019.
Conference Call and Webcast

Kura’s management will host a webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT today, May 4, 2020, to discuss the financial results for the first quarter 2020 and provide a corporate update. The live call may be accessed by dialing (877) 516-3514 for domestic callers and +1 (281) 973-6129 for international callers and entering the conference code: 2085246. A live webcast of the call will be available from the Investors and Media section of the Company’s website at www.kuraoncology.com, and will be archived there for 30 days.

Corcept Therapeutics Announces First Quarter 2020 Financial Results And Provides Corporate Update

On May 4, 2020 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 results for the quarter ended March 31, 2020 (Press release, Corcept Therapeutics, MAY 4, 2020, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-first-quarter-2020-financial [SID1234556958]).

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Financial Highlights

Revenue of $93.2 million, a 44 percent increase from first quarter 2019
GAAP diluted net income of $0.25 per share, compared to $0.15 per share in first quarter 2019
Non-GAAP diluted net income of $0.34 per share, compared to $0.20 per share in first quarter 2019
Cash and investments of $349.0 million, compared to $315.3 million in fourth quarter 2019
Reaffirmed 2020 revenue guidance of $355 – 375 million
Corcept reported quarterly revenue of $93.2 million in the first quarter, compared to $64.8 million in the first quarter of 2019. First quarter GAAP net income was $30.1 million, compared to $18.3 million in the same period last year. Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income in the first quarter was $41.2 million, compared to $24.3 million in the first quarter of 2019. A reconciliation of GAAP to non-GAAP net income is included below.

First quarter operating expenses were $55.5 million, compared to $45.9 million in the first quarter of 2019, primarily due to increased employee recruiting and compensation expense, increased spending to conduct clinical trials in Cushing’s syndrome and solid tumors and increased spending to formulate and manufacture relacorilant, miricorilant and exicorilant.

Cash and investments were $349.0 million at March 31, 2020, an increase of $33.7 million from December 31, 2019. The company reaffirmed its 2020 revenue guidance of $355 – 375 million.

"Our commercial and medical affairs teams did an excellent job supporting physicians during this difficult time," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "COVID-19 poses especially grave risks to patients with Cushing’s syndrome. Hypercortisolism suppresses the immune system and greatly increases the risk of respiratory infection. Now, more than ever, it is important that patients with Cushing’s syndrome receive optimal treatment.

"The COVID-19 pandemic’s future impact on Corcept is difficult to estimate," said Dr. Belanoff. "While the heightened vulnerability of patients with Cushing’s syndrome and their greater than usual need to adhere to their prescribed regimen tends to increase demand for Korlym, restrictions imposed by public health authorities, hospitals and medical practices make it harder for us to reach physicians and harder for physicians to diagnose and treat new patients. It is difficult to predict how the balance of these countervailing forces will shift as the year progresses. That is why, despite an outstanding first quarter, we have not changed our annual revenue guidance.

"Our clinical development programs continue to advance, although the pandemic has made progress more difficult," Dr. Belanoff continued. "Some clinical trial sites, particularly those at academic centers, have suspended new patient enrollments. Some have stopped initiating new trials. At other sites, patient enrollment and study initiations have continued, but at a slower pace. The effect of these changes varies from trial-to-trial. Slowed enrollment will cause our GRACE trial to take longer to complete. The start of our Phase 3 GRADIENT trial and our planned trials in adrenocortical cancer and non-alcoholic steatohepatitis (NASH) have been delayed one quarter.

"By contrast, we still expect results from our Phase 2 trial in ovarian cancer in the first half of next year and to complete dose-finding in our trial of exicorilant plus enzalutamide (Xtandi) to treat castration-resistant prostate cancer this year. The planned starts of our Phase 3 trial in pancreatic cancer and our additional Phase 2 trial in antipsychotic-induced weight gain have not changed."

Cushing’s Syndrome

Phase 3 trial of relacorilant to treat patients with Cushing’s syndrome (GRACE) continues at sites in the United States, Europe and Israel; NDA filing planned for second quarter 2022
Phase 3 trial of relacorilant to treat patients with Cushing’s syndrome caused by adrenal adenomas (GRADIENT) expected to start in second quarter 2020
"Although the COVID-19 pandemic has greatly slowed new patient screening and enrollment and delayed the opening of our last few clinical trial sites in the GRACE study," said Andreas Grauer, MD, Corcept’s Chief Medical Officer, "patients who have already enrolled have continued to participate and we expect the pace of enrollment to increase as public health restrictions ease. We now plan to submit our relacorilant NDA for Cushing’s syndrome in the second quarter of 2022.

"This quarter, we plan to start our Phase 3 GRADIENT trial of relacorilant in patients with Cushing’s syndrome caused by adrenal adenomas," said Dr. Grauer. GRADIENT is the first randomized, double-blind, placebo-controlled trial in patients with this etiology of Cushing’s syndrome, with a planned enrollment of 130 patients at sites in the United States and Europe. Half of the patients will receive relacorilant and the other half will receive placebo for six months. The primary endpoints will be improvement in glucose metabolism and hypertension. Many planned GRADIENT sites are currently participating in GRACE.1

Solid Tumors

Controlled, Phase 2 trial of relacorilant plus nab-paclitaxel (Abraxane) to treat metastatic ovarian cancer enrolling patients at sites in the United States and Europe; results expected in first half 2021
Phase 3 trial of relacorilant plus nab-paclitaxel in metastatic pancreatic cancer (RELIANT)
to start in second quarter 2020
Selection of optimum dose of exicorilant plus enzalutamide in castration-resistant prostate cancer expected by year-end
Phase 1b trial of relacorilant plus PD-1 checkpoint inhibitor pembrolizumab (Keytruda) to treat patients with metastatic or unresectable adrenal cancer to start in third quarter 2020
"While the COVID-19 pandemic has slowed the pace of enrollment and clinical trial site activation, our oncology program continues to advance," said Dr. Grauer. "We expect results from our Phase 2 trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant, metastatic ovarian cancer in the first half of 2021. This quarter, we plan to start our Phase 3 RELIANT trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer."

RELIANT will be an open-label trial in which 80 patients receive relacorilant plus nab-paclitaxel, with the primary endpoint being the objective response rate, assessed by RECIST criteria. An interim analysis will be performed on data from the first 40 patients. "RELIANT’s design incorporates guidance from the FDA," said Dr. Grauer. "We believe that sufficiently positive results would support accelerated approval in patients with metastatic pancreatic cancer."

"Next quarter, we also plan to start a 20-patient, open-label, Phase 1b trial of relacorilant combined with the PD-1 checkpoint inhibitor pembrolizumab in patients with metastatic or unresectable adrenal cancer that produces cortisol. These patients have a poor response to pembrolizumab monotherapy," Dr. Grauer added. "Patients with adrenal cancer often have Cushing’s syndrome as well, because their tumors produce excess cortisol. We believe relacorilant may treat these patients’ Cushing’s syndrome and, by countering cortisol’s immunosuppressive effect, help pembrolizumab achieve its full effect."

Metabolic Diseases

Results of 900 mg cohort in Phase 1b study confirm miricorilant’s activity in reducing antipsychotic-induced weight gain (APIWG)
Phase 2 trial of miricorilant to reverse long-standing APIWG to start in fourth quarter
Phase 2 trial of miricorilant to treat patients with NASH to start in first quarter 2021
"Results from the 900 mg cohort in our Phase 1b study of miricorilant to attenuate APIWG confirm the exciting finding from the 600 mg cohort that miricorilant is an active medication," said Dr. Grauer. Despite being treated for only two weeks and receiving miricorilant at considerably lower exposures than we plan to investigate in future trials, subjects given olanzapine plus miricorilant gained less weight and had lower triglycerides and less sharply elevated liver enzymes than subjects who received olanzapine plus placebo. No side effects, beyond those seen with olanzapine, were observed.

We plan to publish the trial’s full results later this year.

"We hope that our ongoing GRATITUDE trial will confirm our positive Phase 1b results," added Dr. Grauer. GRATITUDE is a multi-site, double-blind, placebo-controlled, Phase 2 trial of miricorilant in 100 patients with schizophrenia and recent APIWG. Study participants are randomized to receive either miricorilant or placebo in addition to their established antipsychotic medication regimen for 12 weeks.2

In the fourth quarter, we plan to test a more potent formulation of miricorilant in a double-blind, placebo-controlled, Phase 2 trial in patients with long-standing APIWG. In the first quarter of 2021, using the same formulation, we plan to start a double-blind, placebo-controlled, Phase 2 trial of miricorilant to treat patients with NASH, a serious liver disorder that afflicts millions of people.

Conference Call

We will hold a conference call on May 4, 2020, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, dial 1-800-458-4121 from the United States or 1-323-794-2093 internationally approximately ten minutes before the start of the call (passcode 2827359). A replay will be available through May 18, 2020 at 1-888-203-1112 in the United States and 1-719-457-0820 internationally (passcode 2827359).

APOLLO ENDOSURGERY, INC. REPORTS FIRST QUARTER 2020 RESULTS

On May 4, 2020 Apollo Endosurgery, Inc. ("Apollo") (Nasdaq: APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, reported financial results for the first quarter ended March 31, 2020 (Press release, Apollo Endosurgery, MAY 4, 2020, View Source [SID1234556957]).

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First Quarter 2020 and Recent Highlights

•First quarter U.S. OverStitch Endoscopic Suturing System ("ESS") sales increased 25% to $3.8 million
•Implemented cost reduction initiatives to preserve liquidity in response to the COVID-19 pandemic, which are expected to save more than $7 million in cash during the second quarter
Todd Newton, CEO of Apollo, said, "The first two months of 2020 started very well for Apollo, particularly in respect of ESS demand in our direct markets. However, the COVID-19 pandemic and resulting actions brought an unprecedented decline in the allocation of global healthcare resources for elective or deferrable medical procedures, including those that use our products, and the impact on our March sales was significant. We expect the second quarter of 2020 will continue to be very challenging. In response, we have implemented aggressive cost reduction measures for the second quarter to preserve capital to the maximum extent possible, while maintaining the flexibility to respond to demand signals and positioning the Company to thrive again as procedures return."
U.S. ESS product sales increased 25% to $3.8 million for the first quarter of 2020. Outside the US ("OUS"), ESS product sales decreased 12% (8% in constant currency) to $3.1 million for the first quarter of 2020 primarily due to the onset of the COVID-19 pandemic delaying distributor orders scheduled to ship in March. OUS ESS product sales in direct markets, excluding Brazil which we transitioned from a direct market to a distributor market in early March, increased 11% (15% in constant currency). Worldwide, ESS product sales increased 5% (8% in constant currency) to $6.8 million for the first quarter of 2020.
U.S. IGB sales decreased by $0.6 million for the first quarter of 2020 and OUS IGB product sales decreased $0.2 million, or 8% (5% in constant currency), for the first quarter of 2020 primarily due to the COVID-19 impact in our direct markets which offset an increase in IGB distributor orders.
In total, U.S. Endoscopy sales increased 4% to $4.7 million for the first quarter of 2020. Worldwide Endoscopy product sales decreased 4% (2% in constant currency) to $10.4 million for the first quarter of 2020. ESS product sales represented 66% of total Endoscopy sales for the first quarter of 2020, compared with 60% for the first quarter of 2019.
Total GAAP revenue reported in the first quarter of 2019 included $2.3 million related to transition services that we rendered in that period related to the Surgical product line that we divested in December of 2018 compared to $0.2 million in the first quarter of 2020. As a result, total GAAP revenue reported for the first quarter of 2020 declined by $2.5 million compared to the first quarter of 2019.
Gross margin for the first quarter of 2020 was 53%, compared to 55% for the first quarter of 2019 when we realized gross margin on the continuing transition services rendered on the Surgical product line. Gross margin realized on our Endoscopy products increased 124 basis points in the first quarter of 2020 compared to the first quarter of 2019.
While total operating expenses, as reported, increased $2.5 million for the first quarter of 2020 compared to the first quarter of 2019, this is due to a one-time settlement gain of $5.6 million settlement gain that reduced operating expenses in the first quarter of 2019. Excluding the one-time settlement gain, total operating expenses decreased $3.1 million for the first quarter of 2020 and our loss from operations decreased by $1.5 million, or 18%. This reduction in recurring operating expenses was primarily the result of lower direct to consumer advertising, lower selling costs such as compensation and travel, and lower clinical trial costs. Net loss for the first quarter 2020 was $10.3 million compared to $2.8 million for the first quarter 2019.
Cash, cash equivalents and restricted cash were $24.0 million as of March 31, 2020.
COVID-19 Response
As a result of the COVID-19 outbreak, a number of countries, particularly countries in Europe that comprise the majority of our OUS sales and the United States, implemented a variety of public health interventions in March to reduce the risk of disease transmission and conserve healthcare resources for addressing the community health needs of COVID-19. These measures also to a large degree paused patient access to elective or deferrable procedures, including those that use our products.

In response, Apollo has taken several interim actions to preserve cash while maintaining customer support and critical growth projects. We initially reduced 2019 cash bonuses, implemented compensation reductions across our workforce, reduced or delayed inventory purchase commitments, and cut operating expenditures across the company. We took additional actions in mid-April, including the furlough of approximately 90 employees across our global workforce and capping annual compensation rates at $100,000. The objective of these temporary cost reductions is to keep our cash use during the second quarter of 2020 at the same level we were expecting prior to COVID-19.
While taking these steps, we have maintained sufficient commercial resources in key markets to support essential customer needs and monitor product demand trends. We are also proceeding with critical growth projects, including the MERIT trial and other reimbursement initiatives, new product development efforts for suturing in the lower GI tract, and select projects expected to improve critical aspects of our supply chain.
Conference Call
Apollo will host a conference call on May 4, 2020 at 3:30 p.m. Central Time / 4:30 p.m. Eastern Time to discuss operating results for the first quarter ended March 31, 2020.
To participate in the conference call dial 844-369-8770 for domestic callers and +1-862-298-0840 for international callers. A live webcast of the conference call will be made available on the "Events and Presentations" section of our Investor Relations website: ir.apolloendo.com.
A replay of the webcast will be made available on Apollo’s website, www.apolloendo.com following the event.