On November 5, 2020 Orgenesis Inc. (NASDAQ: ORGS) ("Orgenesis" or the "Company"), a global biotech company working to unlock the full potential of cell and gene therapies, reported a business update for the third quarter of 2020. Revenue increased 40% to $1.7 million compared to $1.2 million for the third quarter of 2019 (Press release, Orgenesis, NOV 5, 2020, View Source [SID1234570022]). The Company also reported approximately $88.8 million of cash and cash equivalents as of September 30, 2020.

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Vered Caplan, CEO of Orgenesis, stated, "Orgenesis continues to gain traction with a disruptive, point of care strategy for potentially commercializing life-changing treatments at reduced costs for large numbers of patients. In Q3 2020, we expanded the POCare Platform to include new POCare Therapeutics, Technologies, and a growing global Network."

"Orgenesis recently completed an acquisition of Koligo Therapeutics, Inc., a regenerative medicine company, including substantially all of the assets of Tissue Genesis, LLC. This acquisition helped to expand our therapeutic and technology resources, while adding a highly experienced US team to help further bolster Orgenesis’ POCare Network in the US."

"On the therapeutic front, Orgenesis is focused on several key verticals, including immuno-oncology, anti-viral, and metabolic/auto-immune diseases. A near-term goal is expanding the availability of KYSLECEL from the recent Koligo acquisition. KYSLECEL is commercially available in the United States for chronic and recurrent acute pancreatitis. We are also planning patient recruitment for a phase 2 randomized clinical trial of KT-PC-301, subject to FDA review and clearance of an investigational new drug (IND) application. KT-PC-301 is an autologous clinical development stage cell therapy candidate for COVID-19-related Acute Respiratory Distress Syndrome, which we also acquired as part of the Koligo acquisition. Additionally, Orgenesis is preparing for a Phase 2 study of Ranpirnase for the treatment of conditions caused by human papilloma virus pending a planned IND submission to the FDA.

"Orgenesis intends to leverage our network of regional partners to advance the development and commercialization of our therapeutic pipeline. Towards this end, our partners have committed to funding the clinical programs. In turn, Orgenesis typically grants its partners geographic rights in exchange for future royalties, and a partnership with Orgenesis to support the supply of the targeted therapies. Through this unique model, Orgenesis has already signed contracts, which we expect to generate over $40 million in revenue over the next three years, if fully realized. There are also plans to continue to develop, license and form partnerships around a variety of POCare Technologies to support work in areas such as Tumor Infiltrating Lymphocytes (TILS), CAR-T, CAR-NK, dendritic cell therapies, and mesenchymal stem cell (MSC) based therapies."

"Finally, Orgenesis is ready to announce advancements on proprietary, cell and gene processing units and labs that are being developed using first-in-class automation technologies. Orgenesis Mobile Processing Units & Labs ("OMPULs") are designed to provide an economical industrial alternative for our POCare Network partners to produce cell and gene therapies at the point of care. Orgenesis intends to roll these OMPULs out in centers that we are establishing across the US, Europe, Asia, and the Middle East."

The Company’s complete financial results are available in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 5, 2020 which is available at www.sec.gov and on the Company’s website.

On November 5, 2020 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best–in-class treatments to address some of the most important unmet patient needs, reported financial results for the three and nine months ended September 30, 2020 and highlighted recent corporate updates (Press release, Heron Therapeutics, NOV 5, 2020, View Source [SID1234570021]).

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Recent Corporate Updates

Pain Management Franchise

European Commission Authorization for ZYNRELEF for the Treatment of Postoperative Pain: In September 2020, the European Commission (EC) granted a marketing authorization for ZYNRELEF (formerly known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. The marketing authorization follows the European Medicines Agency’s positive opinion from the Committee for Medicinal Products for Human Use in July 2020. The EC’s centralized marketing authorization is valid for the 27 countries that are members of the European Union (EU), and the other countries in the European Economic Area (EEA). We are currently assessing the evolving global environment for pharmaceuticals and developing a coordinated global marketing strategy, and at this time we anticipate making ZYNRELEF available to patients in Europe during the second half of 2021.

Successful Outcome of FDA Type A Meeting to Discuss HTX-011 for the Management of Postoperative Pain: In September 2020, we announced a successful Type A meeting with the U.S. Food and Drug Administration (FDA) in which alignment was reached on the plans for Heron to resubmit the New Drug Application (NDA) for HTX-011 for the management of postoperative pain in the fourth quarter of 2020.
CINV Franchise

CINV Net Product Sales: For the three and nine months ended September 30, 2020, chemotherapy–induced nausea and vomiting (CINV) franchise net product sales were $20.0 million and $68.0 million, respectively, compared to $42.6 million and $110.9 million, respectively, for the same periods in 2019.

CINVANTI Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and nine months ended September 30, 2020 were $19.8 million and $67.6 million, respectively, compared to $36.4 million and $97.6 million, respectively, for the same periods in 2019. Heron expects the impact of the generic arbitrage to be resolved in 2020, with a return to growth in 2021 and beyond.

SUSTOL Net Product Sales: Net product sales of SUSTOL (granisetron) extended–release injection for the three and nine months ended September 30, 2020 were $0.2 million and $0.4 million, respectively, compared to $6.2 million and $13.3 million, respectively, for the same periods in 2019. On October 1, 2019, the Company discontinued all discounting of SUSTOL, which resulted in significantly lower SUSTOL net product sales. Heron expects SUSTOL to return to growth in 2021 and beyond.

2020 Net Product Sales Guidance: Although Heron anticipates a decrease in new diagnoses and chemotherapy patient starts because of the ongoing COVID-19 pandemic (COVID-19), the Company has increased its 2020 guidance for net product sales for the CINV franchise from a range of $70 million to $80 million to net product sales of $85 million.
"The third quarter was highlighted by the authorization of ZYNRELEF in the EU and we remain focused on resubmitting the New Drug Application for HTX-011 in the U.S. as quickly as possible in order to bring this innovative non-opioid medicine to patients suffering from postoperative pain," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "In addition, our CINV franchise is advancing well, with continued strong performance of CINVANTI against a backdrop of arbitrage and the ongoing global pandemic. Based on the strong commercial execution, we are very pleased to increase our guidance for 2020 to $85 million in net product sales."

Financial Results

Net product sales for the three and nine months ended September 30, 2020 were $20.0 million and $68.0 million, respectively, compared to $42.6 million and $110.9 million, respectively, for the same periods in 2019.

Heron’s net loss for the three and nine months ended September 30, 2020 was $58.2 million and $165.0 million, or $0.64 per share and $1.82 per share, respectively, compared to $33.6 million and $146.8 million, or $0.42 per share and $1.85 per share, respectively, for the same periods in 2019. Net loss for the three and nine months ended September 30, 2020 included non-cash, stock-based compensation expense of $11.1 million and $34.2 million, respectively, compared to $9.7 million and $40.3 million, respectively, for the same periods in 2019.

As of September 30, 2020, Heron had cash, cash equivalents and short-term investments of $258.1 million, compared to $391.0 million as of December 31, 2019. Net cash used for operating activities for the nine months ended September 30, 2020 was $132.3 million, compared to $97.6 million for the same period in 2019. Heron expects that its current cash, cash equivalents and short-term investments will be sufficient to fund its operations into 2022.

About HTX-011 for Postoperative Pain (ZYNRELEF in the EU and EEA)

HTX-011, an investigational non-opioid analgesic, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. The FDA granted Breakthrough Therapy designation to HTX-011 and the NDA received Priority Review designation. A complete response letter (CRL) was received from the FDA regarding the NDA for HTX-011 in June 2020 relating to non clinical information. No clinical safety or efficacy issues and no chemistry, manufacturing and controls issues were identified. Heron’s New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was accepted by Health Canada. Heron is working to respond to a list of questions received from Health Canada in July 2020. In September 2020, the EC granted a marketing authorization for ZYNRELEF (also known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. The EC’s centralized marketing authorization is valid for the 27 countries that are members of the EU, and the other countries in the EEA.

About CINVANTI (Aprepitant) Injectable Emulsion

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist (RA). CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the United States prescribing information for CINVANTI is a 30-minute IV infusion or a 2-minute IV injection.

CINVANTI is under investigation for the treatment of COVID-19 as a daily 2-minute IV injection when added to the current standard of care.

Please see full prescribing information at www.CINVANTI.com.

About SUSTOL (Granisetron) Extended-Release Injection

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy).

On November 5, 2020 Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare and other high-burden diseases, reported its third quarter 2020 financial results, and provided recent corporate and program highlights (Press release, Aeglea BioTherapeutics, NOV 5, 2020, View Source [SID1234570020]).

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"Although it’s been a challenging environment for biotech with the global pandemic, we have continued to be productive in our Arginase 1 Deficiency patient identification and engagement efforts. I am pleased with the progress we are making overall as well as specifically at our PEACE trial sites," said Anthony Quinn, M.B Ch.B, Ph.D., president and chief executive officer of Aeglea. "I am also excited by the momentum we are building in our Homocystinuria program with the recent granting of U.S. Orphan Drug Designation and a positive opinion for EU Orphan Drug Designation for ACN00177."

Recent Highlights and Updates

Pegzilarginase in Arginase 1 Deficiency

In September, Aeglea announced the PEACE Phase 3 pivotal trial was more than 50% enrolled with nearly twice the number of patients needed to complete enrollment identified at active trial sites. Enrollment for the trial is anticipated to be completed in January 2021.
As of September, Aeglea has identified over 250 Arginase 1 Deficiency patients in addressable markets, a 25% increase relative to the prior year. The number of currently identified patients represents more than 50% and 30% of the estimated genetic prevalence populations in the U.S. and EU5, respectively.
ACN00177 in Homocystinuria

In October, Aeglea announced the U.S. Food and Drug Administration granted Orphan Drug Designation to ACN00177 for the treatment of Homocystinuria.
Additionally, the European Medicines Agency Committee for Orphan Medicinal Products issued a positive opinion recommending Orphan Drug Designation for ACN00177 for the treatment of Homocystinuria in the European Union.
Corporate

In October, the Company strengthened its financial position with proceeds from shares of common stock sold under its ATM program, resulting in gross proceeds of $25 million, extending its cash runway into 2023.
Upcoming Events

Aeglea will be attending the following virtual investor conferences in the fourth quarter:

Piper Sandler 32nd Annual Virtual Healthcare Conference, December 1-3
3rd Annual Evercore ISI HealthCONx Conference, December 1-3
Third Quarter 2020 Financial Results

As of September 30, 2020, Aeglea had available cash, cash equivalents, marketable securities and restricted cash of $141.5 million. In addition, in October 2020 the Company raised approximately $24.6 million in net proceeds from shares of common stock sold under its ATM program. Based on Aeglea’s current operating plan, and taking into account the net offering proceeds, management believes it has sufficient capital resources to fund anticipated operations into 2023.

Research and development expenses totaled $12.5 million for the third quarter of 2020 and $17.8 million for the third quarter of 2019. The decrease was primarily associated with completing certain manufacturing and pre-commercial activities for Aeglea’s lead product candidate, pegzilarginase, completing a Phase 1/2 clinical trial in patients with Arginase 1 Deficiency and closing cancer trials; offset by a ramp-up in manufacturing for ACN00177 in Homocystinuria and higher personnel-related expenses.

General and administrative expenses totaled $5.7 million for the third quarter of 2020 and $4.3 million for the third quarter of 2019. This increase was primarily due to ramping-up commercial capabilities and additional facilities to support company growth.

Net loss totaled $18.0 million and $21.6 million for the third quarter of 2020 and 2019, respectively, with non-cash stock compensation expense of $1.7 million and $1.4 million for the third quarter of 2020 and 2019, respectively.

About Pegzilarginase in Arginase 1 Deficiency

Pegzilarginase is an enhanced human arginase that enzymatically lowers levels of the amino acid arginine. Aeglea is developing pegzilarginase for the treatment of patients with Arginase 1 Deficiency (ARG1-D), a rare debilitating, progressive disease presenting in childhood with persistent hyperargininemia, spasticity, developmental delay, intellectual disability, seizures and early mortality. Pegzilarginase is intended for use as an enzyme therapy to reduce elevated blood arginine levels in patients with ARG1-D. Aeglea’s Phase 1/2 and Phase 2 open-label extension data for pegzilarginase in patients with ARG1-D demonstrated clinical improvements and sustained lowering of plasma arginine. The Company’s single, global pivotal Phase 3 PEACE trial is designed to assess the effects of treatment with pegzilarginase versus placebo over 24 weeks with a primary endpoint of plasma arginine reduction.

About ACN00177 in Homocystinuria

Aeglea is developing ACN00177 for the treatment of patients with cystathionine beta synthase (CBS) deficiency, also known as Classical Homocystinuria. Homocysteine accumulation plays a key role in multiple progressive and serious disease-related complications, including thromboembolic vascular events, skeletal abnormalities including severe osteoporosis, developmental delay, intellectual disability, lens dislocation and severe near-sightedness. ACN00177 has been designed as a novel recombinant human enzyme, which degrades the amino acid homocysteine and its related homocystine dimer. With this mechanism, ACN00177 is intended to lower the abnormally high blood levels of homocysteine in patients with Homocystinuria. Preclinical data demonstrated that ACN00177 improved important disease-related abnormalities and survival in a mouse model of Homocystinuria. The Company initiated a Phase 1/2 trial in the second quarter of 2020 and continues patient identification and administrative activities. The timing of first patient dosing in this Phase 1/2 trial will depend on determinations by individual sites as they adjust to impacts from COVID-19. ACN00177 has been granted Orphan Drug Designation by the U.S. FDA and received a positive opinion on Orphan Drug Designation from the European Medicines Agency.

On November 5, 2020 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) ("Merrimack" or the "Company") reported its third quarter 2020 financial results for the period ended September 30, 2020 (Press release, Merrimack, NOV 5, 2020, View Source [SID1234570019]).

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"We are pleased that both Ipsen Pharmaceuticals and Elevation Oncology continue to enroll patients in separate clinical stage programs which could result in milestone payments to Merrimack." said Gary Crocker, Chairman of Merrimack’s Board of Directors. "We remain focused on conserving cash and reduction of our operating expenses to ensure that we have sufficient financial resources to capture future potential milestone payments from Ipsen and Elevation."

Second Quarter 2020 Financial Results

Merrimack reported net loss of $1.0 million for the third quarter ended September 30, 2020, or $0.08 per basic share, compared to a net loss of $0.7 million, or $0.05 per basic share, for the same period in 2019.

No gain on sale of assets was recognized for the third quarter ended September 30, 2020 compared to $3.5 million for the same period in 2019.

General and administrative expenses for the third quarter ended September 30, 2020 were $1.0 million, compared to $4.3 million for the same period in 2019.

As of September 30, 2020, Merrimack had cash and cash equivalents and investments of $15.8 million, compared to $16.6 million as of December 31, 2019.

As of September 30, 2020, Merrimack had 13.4 million shares of common stock outstanding.

Updates on Programs Underlying Potential Milestone Payments

Ipsen

On October 22, 2020 Ipsen released its third quarter financial results. As part of that update, Ipsen reported that it is continuing to study ONIVYDE in Phase III clinical trials in first line pancreatic ductal adenocarcinoma and in second line small cell lung cancer.

Elevation Oncology

On October 26, 2020 Elevation Oncology announced the presentation of preclinical data on its HER3 program. This announcement included confirmation that Elevation’s phase II CRESTONE study is currently enrolling patients.

On November 5, 2020 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, eported financial results for the third quarter ended September 30, 2020 and provided business updates, including confirming completion of a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) for vadadustat (Press release, Akebia, NOV 5, 2020, View Source [SID1234570018]). Vadadustat is Akebia’s investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) in development for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis and not on dialysis.

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"We recently completed our pre-NDA meeting with the FDA. This was an important milestone for our vadadustat development program, and we remain on track to submit an NDA to the FDA as early as possible next year. A key component of this NDA is the positive data from our global Phase 3 INNO2VATE program for the treatment of anemia due to CKD in adult patients on dialysis, which we shared most recently at ASN Kidney Week. These data were clear and consistent, and showed that vadadustat achieved both the primary and key secondary efficacy endpoints, as well as the primary and key secondary safety endpoints of the program for patients on dialysis. Based on our pre-NDA meeting, we remain confident that these results support the potential approval of vadadustat for the treatment of anemia due to CKD in adult patients on dialysis," said John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. "Subject to regulatory review and approval, we believe vadadustat has the potential to be a new oral standard of care to help address the unmet needs of adult patients on dialysis, including both incident and prevalent dialysis patients. We believe this could translate into a potential $2 billion market opportunity in the U.S., alone. Together with our collaborator, Otsuka, we look forward to bringing this innovative therapy to patients on dialysis globally, if approved."

Butler continued, "The pre-NDA meeting also allowed us the opportunity to clarify key questions regarding data from PRO2TECT, our global Phase 3 program for the treatment of anemia due to CKD in adult patients not on dialysis, and we look forward to working with the FDA in their review of these data. While the PRO2TECT data showed that vadadustat achieved both the primary and key secondary efficacy endpoints, it did not meet the program’s primary safety endpoint for patients not on dialysis, and we remain appropriately cautious in our outlook for potential approval of vadadustat in patients not on dialysis. Importantly, we believe the PRO2TECT data will not adversely impact the potential approvability of vadadustat for the treatment of anemia due to CKD in adult patients on dialysis."

Akebia plans to submit a New Drug Application (NDA) to the FDA for vadadustat as early as possible in 2021 for two indications: (1) the treatment of anemia due to CKD in adult patients on dialysis, and (2) the treatment of anemia due to CKD in adult patients not on dialysis. In addition, Akebia and its collaborator, Otsuka Pharmaceutical Co. Ltd., are working in close collaboration to prepare a Marketing Authorization Application (MAA) for submission to the European Medicines Agency (EMA) next year.

Recent Business Highlights

In October, the Company presented data from its global Phase 3 program at American Society of Nephrology Kidney Week 2020 Reimagined (ASN Kidney Week). Akebia’s global Phase 3 program consists of two programs that evaluated the efficacy and safety of vadadustat versus darbepoetin alfa for the treatment of anemia due to CKD in adult patients on dialysis (INNO2VATE) and not on dialysis (PRO2TECT).
Highlights of INNO2VATE ASN Kidney Week Presentation: As previously reported in May 2020, vadadustat achieved the primary and key secondary efficacy endpoints and the primary safety endpoint of the INNO2VATE program, defined as non-inferiority of vadadustat versus darbepoetin alfa in time to first occurrence of a major adverse cardiovascular event (MACE), which is the composite of all-cause mortality, non-fatal myocardial infarction (MI), or non-fatal stroke, across both INNO2VATE studies. Newly presented INNO2VATE data showed that vadadustat also achieved non-inferiority to darbepoetin alfa on key secondary safety endpoints including expanded MACE, cardiovascular MACE, cardiovascular mortality, and all-cause mortality.
Highlights of PRO2TECT ASN Kidney Week Presentation: As previously reported in September 2020, vadadustat achieved the primary and key secondary efficacy endpoints of the PRO2TECT program, but did not meet the primary safety endpoint. Newly presented pre-specified regional analyses of the PRO2TECT program showed vadadustat demonstrated no clinically meaningful increase in cardiovascular risk compared to darbepoetin alfa in analyses of MACE, expanded MACE and all-cause mortality in U.S. patients treated to a target hemoglobin (Hb) range of 10 to 11 g/dL, consistent with U.S. treatment guidelines.
In October, Akebia and Otsuka launched Balancing Anemia Due to CKD, a campaign and website designed to increase awareness and education of anemia due to CKD among healthcare providers with the goal of improving the management of this disease for patients.
In August, the Company announced the launch of vadadustat in Japan by Mitsubishi Tanabe Pharma Corporation (MTPC), Akebia’s partner in Japan, as a treatment for anemia due to CKD in both adult patients on dialysis and not on dialysis under the trade name VAFSEO.
In July, the Company announced an investigator-sponsored research study by The University of Texas Health Science Center at Houston (UTHealth) in Houston, Texas, evaluating the use of vadadustat as a potential therapy to prevent and lessen the severity of acute respiratory distress syndrome (ARDS), a complication of COVID-19. The study is currently underway and actively enrolling patients.
Third Quarter Financial Results

Revenues: Total revenue was $60.0 million for the third quarter of 2020 compared to $92.0 million for the third quarter of 2019. The decline versus the prior year period was driven by lower collaboration revenue consistent with the Company completing the INNO2VATE and PRO2TECT studies.
Collaboration revenue was $25.6 million for the third quarter of 2020 compared to $62.0 million in the third quarter of 2019, and included $0.4 million in royalty revenue related to the commercial sale of vadadustat (VAFSEO) in Japan from MTPC.
Net product revenue for Auryxia (ferric citrate) was $34.4 million for the third quarter of 2020 compared with $30.0 million in the third quarter of 2019, an increase of 14.6 percent.
COGS: Cost of goods sold was $30.3 million for the third quarter of 2020 compared to $38.3 million for the third quarter of 2019 and includes the impact of $9.9 million in non-cash inventory write-downs largely related to a previously disclosed manufacturing quality issue related to Auryxia.
R&D Expenses: Research and development expenses were $46.9 million for the third quarter of 2020 compared to $74.5 million for the third quarter of 2019. The decline versus the prior year period was primarily driven by a decrease in costs consistent with the Company completing the INNO2VATE and PRO2TECT studies.
SG&A Expenses: Selling, general and administrative expenses were $40.2 million for the third quarter of 2020 compared to $34.2 million for the third quarter of 2019. The increase was primarily a result of higher professional service fees related to marketing and pre-commercialization activities for vadadustat and legal fees.
Net Loss: Net loss was $60.0 million for the third quarter of 2020 compared to $54.6 million for the third quarter of 2019. The increase in net loss compared to the prior year period was due primarily to lower total revenue and more specifically, lower collaboration revenue, partially offset by lower operating expenses.
Cash Position: Cash, cash equivalents and available-for-sale securities as of September 30, 2020 were $269.3 million. The Company expects its cash resources to fund its current operating plan beyond the expected U.S. launch of vadadustat, assuming regulatory approval.
Conference Call
Akebia will host a conference call at 9:00 a.m. Eastern Time today, Thursday, November 5th, to discuss its third quarter financial results and recent business highlights. To listen to the conference call, please dial (877) 458-0977 (domestic) or (484) 653-6724 (international) using conference ID number 2860285. The call will also be webcast LIVE and can be accessed via the Investors section of the Company’s website at View Source

A replay of the conference call will be available two hours after the completion of the call through November 11, 2020. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference ID number 2860285. An online archive of the conference call can be accessed via the Investors section of the Company’s website at View Source