On November 12, 2019 Merck , a leading company in the scientific and technological sector, reported that it has signed a license agreement that provides Evotec SE with access to Merck’s base CRISPR intellectual property (Press release, Merck & Co, NOV 12, 2019, View Source [SID1234551027]). Evotec, an international biotech company based in Hamburg (Germany), will use Merck’s genome CRISPR technology to create modified cell lines for Evotec’s commercial and internal research purposes.

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Merck’s CRISPR license to Evotec is the impetus for important drug testing and discovery, which will accelerate research and lead to new therapy development
Merck’s CRISPR license to Evotec is the impetus for important drug testing and discovery, which will accelerate research and lead to new therapy development

"This CRISPR license will be an engine for important drug tests and discoveries that promise to accelerate research and generate the development of new treatments," said Udit Batra , a member of the Merck Board of Directors and CEO of Life Science. "Merck has been at the forefront of innovation in genome modification for 15 years and continues to work with the sector and the academic environment to solve complex problems through our patented CRISPR technology, in an ethical and responsible manner."

Evotec plans to use Merck’s CRISPR intellectual property portfolio to develop very precise tests to determine the biology and toxicity of possible drugs during the drug development cycle.

"Evotec is proud to be able to continue its solid collaboration with Merck by licensing its revolutionary CRISPR technology," said Craig Johnstone , director of Operations for Evotec. "Our vision and passion for innovation includes the use of CRISPR technology to test and improve the effectiveness of the new drugs we develop, in order to alleviate the suffering of patients with diseases with insufficient attention from around the world."

This new license reinforces previous collaborations between Merck and Evotec. In November 2016, the companies signed a series of agreements through which Evotec would provide selection services thanks to Merck’s set of genetic reagents, including CRISPR and ARNhc banks. The combination of access to Merck genome modification banks with Evotec’s selection knowledge offers a faster way to explore and identify new pharmacological targets.

Merck has 20 CRISPR patents worldwide in terms of methods and composition, including the fundamental technology of CRISPR Cas9 for genetic integration into mammalian cells.

Merck supports genome editing research paying close attention to ethical and legal norms. The company has created an external and independent Bioethics Advisory Body in order to offer research orientations in which the company participates, such as the work in which genome editing is studied or used. Merck has also defined a clear operational position that takes into account scientific and social problems to inform promising therapeutic approaches for use in research and applications.

All Merck press releases are distributed by email at the same time they are published on the Merck website. To register, modify your selection or unsubscribe from this service, visit www.merckgroup.com/subscribe .

On November 12, 2019 IVERIC bio, Inc. (Nasdaq: ISEE) reported further details of the clinical trial results for the Company’s Zimura (avacincaptad pegol) program in geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD), reviewed the Company’s financial results for the third quarter 2019 and provided a general business update (Press release, Ophthotech, NOV 12, 2019, View Source [SID1234551043]).

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Zimura (avacincaptad pegol) Highlights

On October 28, 2019, IVERIC bio provided topline data confirming that Zimura (avacincaptad pegol), the Company’s complement factor C5 inhibitor, met its prespecified primary endpoint in reducing the mean rate of geographic atrophy (GA) growth in patients with dry age-related macular degeneration (AMD). Today, the Company provided further clinical details and the development strategy for Zimura in GA secondary to AMD. These announcements will be discussed during today’s conference call/webcast (also see the second press release issued earlier today and the press release issued on October 28, 2019.)

"We are excited to have achieved a major milestone with our recent Zimura clinical trial results in geographic atrophy secondary to dry AMD and we look forward to start enrolling patients in a second pivotal clinical trial in the first quarter of 2020. We believe these events have the potential to be a catalyst for our company," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "IVERIC bio is now in a strong position, with a diversified, retina-focused portfolio, including both a late stage clinical program for a large market retinal disease and early stage gene therapy programs in inherited retinal diseases. We are committed to efficiently progressing these programs with the goal of continuing to create value for our shareholders."

Gene Therapy Highlights

Orphan IRD Gene Therapy Programs

IC-100: Rhodopsin-Mediated Autosomal Dominant Retinitis Pigmentosa (RHO-adRP)
Natural history studies and IND-enabling activities for IC-100 are on track. The Company expects to initiate a Phase 1/2 clinical trial for IC-100 in patients with rhodopsin mediated adRP in the second half of 2020.

IC-200: BEST1-Related IRDs
Natural history studies and IND-enabling activities for IC-200 are on track.

The Company expects to initiate a Phase 1/2 clinical trial for IC-200 in patients with BEST1 related retinal diseases during the first half of 2021.

miniCEP290: Leber Congenital Amaurosis Type 10 (LCA10)
Encouraging results from the Company’s collaboration with the University of Massachusetts Medical School (UMass Medical School) in its miniCEP290 program led the Company to exercise its option and, in July 2019, the Company entered into an exclusive global license agreement with the University of Massachusetts for rights to develop and commercialize mutation independent novel AAV minigene therapy product candidates for the treatment of LCA10, which is due to mutations in the CEP290 gene and is the most common type of LCA. The Company plans to provide an update on the lead minigene construct in early 2020.

miniABCA4 Program for Stargardt Disease (STGD1)
The Company, through its collaborative sponsored research agreement with UMass Medical School, is evaluating several ABCA4 minigene constructs in both in vitro and in vivo experiments. The Company expects to have results from the miniABCA4 program in 2020.

miniUSH2A: USH2A-Related IRDs Including Usher Syndrome Type 2A and USH2A-Associated Nonsyndromatic Autosomal Recessive Retinitis Pigmentosa
In July 2019, the Company entered into a sponsored research agreement with UMass Medical School and an exclusive option agreement with the University of Massachusetts for rights to develop and commercialize novel AAV gene therapy product candidates utilizing a mutation independent minigene therapy approach for the treatment of USH2A-related IRDs. This group of orphan IRDs include Usher syndrome Type 2A and USH2A-associated nonsyndromatic autosomal recessive retinitis pigmentosa.

On October 29, 2019, Abraham Scaria, PhD was appointed to the position of Chief Scientific Officer. Dr. Scaria will lead the Company’s research and pre-clinical gene therapy activities. Dr. Scaria’s extensive experience includes positions at Genzyme, Sanofi and most recently at Casebia Therapeutics, leading multiple ocular gene therapy programs.

Second Quarter 2019 Financial Results
Operational Update
As of September 30, 2019, the Company had $94.9 million in cash and cash equivalents. The Company reaffirms its estimate that year-end 2019 cash and cash equivalents will range between $80 million and $85 million. With the initiation of enrollment for the Company’s second pivotal clinical trial for Zimura in GA planned for the first quarter of 2020, the Company estimates that its cash and cash equivalents will be sufficient to fund its operations and capital expenditure requirements as currently planned through the first half of 2021. These estimates are based on the Company’s current business plan, including the continuation of its current research and development programs. This estimate does not reflect any additional expenditures in the event the Company were to in-license or acquire any new product candidates or commences any new sponsored research programs.

R&D Expenses: Research and development expenses were $10.4 million for the quarter ended September 30, 2019, compared to $9.4 million for the same period in 2018. For the nine months ended September 30, 2019, research and development expenses were $28.1 million compared to $25.6 million for the same period in 2018. Research and development expenses increased primarily due to increases in costs associated with the Company’s gene therapy programs and HtrA1 inhibitor program, offset by decreases in costs associated with the Company’s Zimura programs.

G&A Expenses: General and administrative expenses were $4.7 million for the quarter ended September 30, 2019, compared to $6.0 million for the same period in 2018. For the nine months ended September 30, 2019, general and administrative expenses were $15.4 million compared to $17.9 million for the same period in 2018. General and administrative expenses decreased primarily due to decreases in costs to support the Company’s operations and infrastructure.

Net Income: The Company reported a net loss for the quarter ended September 30, 2019 of $14.4 million, or ($0.35) per diluted share, compared to a net loss of $14.7 million, or ($0.41) per diluted share, for the same period in 2018. For the nine months ended September 30, 2019, the Company reported a net loss of $41.4 million or ($1.00) per diluted share, compared to a net loss of $41.0 million or ($1.13) for the same period in 2018.

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 November 12, 2019 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 888-208-1711 (USA) or 323-994-2082 (International), passcode 5526863. 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 Toll Free), passcode 5526863.

On November 12, 2019 Nippon Kayaku reported that (Press release, Nippon Kayaku, NOV 12, 2019, View Source [SID1234550888])

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1. Consolidated Business Results for the Second Quarter of the Fiscal Year Ending March 31, 2020 (April 1,201 September 30, 2019)

(Figures shown are rounded down to the nearest million yen.)

(1) Consolidated Operating Results

The provisional accounting treatment of the corporate combination that occurred during the third quarter of fiscal
year ended March 31, 2019 has been finalized and the amount of the impact from retrospective adjustments is
reflected in the figures for the first half of fiscal year ended March 31, 2019.

(2) Consolidated Financial Position

3. Consolidated Business Results Forecasts for the Fiscal Year Ending March 31, 2020 (April 1, 2019–March 31, 2020)

(1) Significant changes in subsidiaries during the first half (changes in designated subsidiaries that result in changes
in scope of consolidation): None
(2) Adoption of special accounting methods for presenting the quarterly consolidated financial statements: None
(3) Changes to accounting policies and estimates and restatements
[1] Changes to accounting policies associated with revision of accounting standards or similar items: None
[2] Changes other than [1]: None
[3] Changes to accounting estimates: None
[4] Restatements: None
(4) Number of shares issued (common stock)

[1] Number of shares issued at end of the fiscal period (including treasury stock)
As of September 30, 2019: 177,503,570 shares
As of March 31, 2019: 182,503,570 shares

[2] Number of treasury stock at end of the fiscal period
As of September 30, 2019: 4,359,265 shares

As of March 31, 2019: 9,358,749 shares
[3] Average number of shares during the fiscal period (cumulative)
First half of the fiscal year ending March 31, 2020: 173,144,521 shares
First half of the fiscal year ended March 31, 2019: 173,145,594 shares
* Quarterly summary financial statements are not subject to audit by a certified public accountant or audit firm.
* Analysis related to appropriate use of the business forecasts, and other notes

The information in this report constitutes forward-looking statements regarding future events and performance. This
information is based on the beliefs and assumptions of management in light of information currently available to it
at the time of announcement and subject to a number of uncertainties that may affect future results. Actual business results may differ substantially from the forecasts herein due to various factors. For matters pertaining to business forecasts, please refer to "(3) Analysis of Forward-looking Statements, including Consolidated Business Results Forecasts" on page 3 of the Supplementary Information.

Supplementary Information
Contents
1. Qualitative Information Concerning Results for the Second Quarter 2
(1) Analysis of Operating Results 2
(2) Analysis of Financial Position 3
(3) Analysis of Forward-looking Statements, including Consolidated Business Results Forecasts 3
2. Quarterly Consolidated Financial Statements and Notes to Quarterly Consolidated Financial
Statements

(1) Consolidated Balance Sheets 4
(2) Consolidated Statements of Income & Consolidated Statements of Comprehensive Income 6
(3) Consolidated Statements of Cash Flows 8
(4) Notes to Quarterly Consolidated Financial Statements 10
Notes Regarding Assumptions for the Going Concern 10
Notes in Case of Significant Change in Shareholders’ Equity 10
Segment Information and Other Items 10
Significant Subsequent Events

1. Qualitative Information Concerning Results for the Second Quarter
The figures in the provisional accounting for a business combination in the previous consolidated fiscal year have
been confirmed, and the content confirmed in the provisional accounting is reflected in the figures for the second
quarter of the previous consolidated fiscal year.

(1) Analysis of Operating Results
In the first half of this consolidated fiscal year (April 1 to September 30, 2019), the global economy as a whole saw
slow growth. This was mainly due to the deceleration of external demand in the manufacturing industry, while
consumer spending remained steady on the back of an improved employment and income environment in the U.S.
and Europe. The trend of deceleration in economic growth persisted in China, owing to the impact from trade
friction between the U.S. and China, among other factors. The Japanese economy showed signs of a gradual rebound despite weak exports. This resulted mainly from moderate growth in capital investment and a resurgence in
consumer spending.

Amid these conditions, the Nippon Kayaku Group worked to implement the key themes and resolve the midand long-term key issues outlined in "KAYAKU Next Stage," the mid-term business plan launched this fiscal year.
We worked to cut costs further to reinforce our profit structure, in addition to focusing on strengthening R&D,
optimal allocation of business resources into core businesses, and expanding our overseas business.

Sales for the first half of this consolidated fiscal year outperformed the same period last fiscal year in the functional
chemicals business, the pharmaceuticals business, and the safety systems business, resulting in total net sales of
85,608 million yen, an increase of 749 million yen (0.9%) year-on-year.

Operating income totaled 9,045 million yen, a decrease of 518 million yen (5.4%) year-on-year.
Ordinary income totaled 9,149 million yen, a decrease of 1,902 million yen (17.2%) year-on-year due to an
increase in exchange losses.
Profit attributable to owners of parent was 6,337 million yen, a decrease of 1,136 million yen (15.2%)
year-on-year.
Performance by business segment is as described below.

[Functional Chemicals Business]
Sales stood at 34,141 million yen, an increase of 27 million yen (0.1%) year-on-year.
The functional materials business recorded growth in sales over the same period of the previous fiscal year.
This growth was resulted from strong sales of epoxy resins for smartphones and 5G base stations, which more than
covered for the deceleration in demand from the semiconductor market.

The color materials business outperformed the first half of last fiscal year, boosted by strong sales of colorants
for inkjet printers for industrial applications and materials for thermal paper.

The catalyst business underperformed the same period of the previous fiscal year.

In the Polatechno Group, sales of components for X-ray analysis systems were strong, but sluggish sales of
dye-type polarizing films resulted in underperformance of the Polatechno Group as a whole, compared with the
same period of the previous fiscal year. Segment profit was 2,590 million yen, a decrease of 1,095 million yen (29.7%) year-on-year.

[Pharmaceuticals Business]
Sales stood at 23,225 million yen, an increase of 158 million yen (0.7%) year-on-year.
Pharmaceuticals in Japan recorded growth in sales for the antibody biosimilar, INFLIXIMAB BS for I.V.

Infusion, and for Trastuzumab BS for I.V. infusion. Sales for the pharmaceuticals business as a whole outperformed
the first half of last fiscal year. Growth in sales of the generic anti-cancer drugs OXALIPLATIN for I.V. Infusion
NK, TEMOZOLOMIDE Tab., and other generic anti-cancer drugs boosted performance, despite the year-on-year
underperformance of long-listed products as the switch to generic drugs continued.

Exports as a whole underperformed year-on-year due to a decline in exports of BLEOs and ETOPOSIDEs (anti-cancer drugs), despite year-on-year growth in high potency active pharmaceutical ingredients.

Sales of active pharmaceutical ingredients and contracted production for the Japanese domestic market, and
diagnostic agents underperformed the first half of last fiscal year.

Segment profit totaled 2,409 million yen, an increase of 743 million yen (44.6%) year-on-year

[Safety Systems Business]

Sales stood at 24,071 million yen, an increase of 590 million yen (2.5%) year-on-year.
Business in Japan outperformed the same period of the previous fiscal year due to firm sales of both airbag
inflators and micro gas generators for seatbelt pretensioners.

Nippon Kayaku Co., Ltd.

Summary of Consolidated Financial Results [Japanese GAAP]
For the Second Quarter of the Fiscal Year Ending March 31, 2020
This document is an English translation of the Japanese-language original.

All financial information has been prepared in accordance with generally accepted accounting principles in Japan.

The overseas business saw an increase in the automotive safety component installation rate; however, the
sluggish market in China caused air bag inflators, micro gas generators for seatbelt pretensioners, and squibs all to
underperform the same period of the previous fiscal year.

Segment profit was 3,431 million yen, a decrease of 271 million yen (7.3%) year-on-year.
[Other]Sales totaled 4,170 million yen, a decrease of 27 million yen (0.6%) compared to the same period of the previous Fiscal year.

The agrochemicals business outperformed the same period of the previous fiscal year in both domestic sales
and exports, resulting in year-on-year growth for the business as a whole.

Sales in real estate and other business decreased compared to the same period of the previous fiscal year.
Segment profit totaled 795 million yen, an increase of 137 million yen (20.9%) year-on-year.

(2) Analysis of Financial Position

[1] Status of Assets, Liabilities, and Net Assets

Total assets were 287,017 million yen, a decrease of 6,554 million yen from the end of the previous consolidated
fiscal year. The main decreases were in securities, a decrease of 4,752 million yen; notes and accounts receivable-trade, a decrease of 4,260 million yen; and investment securities, a decrease of 1,749 million yen. The
main increases were in cash and deposits, an increase of 3,432 million yen; and long-term loans receivable, an
increase of 632 million yen.

Liabilities were 58,923 million yen, a decline of 5,605 million yen compared to the end of the previous
consolidated fiscal year. The main decreases were in long-term loans payable, a decrease of 2,177 million yen;
accounts payable-other, a decrease of 1,885 million yen; income taxes payable, a decrease of 917 million yen; and
deferred tax liabilities, a decrease of 675 million yen. The main increase was in notes and accounts payable-trade, an
increase of 570 million yen.

Net assets were 228,093 million yen, a decrease of 949 million yen compared to the end of the previous
consolidated fiscal year. The main decreases were in translation adjustments, a decrease of 3,299 million yen; and
dividends paid, a decrease of 2,597 million yen. The main increase was in profit attributable to owners of parent, an
increase of 6,337 million yen.

[2] Cash Flows Status

Net cash provided by operating activities amounted to 15,746 million yen (versus a cash inflow of 14,465 million
yen during the first half of the previous fiscal year). The positive cash flow was primarily generated from profit
before income taxes of 8,840 million yen, depreciation and amortization of 5,983 million yen, and a decrease in
notes and accounts receivable-trade of 3,577 million yen. The above factors more than compensated for income tax
paid of 3,524 million yen and an increase in inventories of 1,118 million yen.

Net cash used in investing activities totaled 10,450 million yen (versus a cash outflow of 7,950 million yen
during the first half of the previous fiscal year). The net outflow was mainly due to expenditures of 8,702 million
yen for the purchase of property, plant and equipment.

Net cash used in financing activities amounted to 5,167 million yen (versus a cash outflow of 5,907 million yen
during the first half of the previous fiscal year). This was mainly due to expenditures for repayment of long-term
loans of 2,171 million yen and dividends paid of 2,590 million yen.

Reflecting the above cash flow performance, the balance of cash and cash equivalents at the end of the first
half was 51,297 million yen (versus 51,362 million yen during the first half of the previous fiscal year), a decrease
of 1,400 million yen from the end of the previous fiscal year.
(3) Analysis of Forward-looking Statements, including Consolidated Business Results Forecasts

The global economy will benefit from the anticipated firmness of the U.S. and European economies, and this will
affect the future business environment surrounding the Nippon Kayaku Group. However, there is concern over a
downswing in the global economic environment due to increased uncertainty over the future caused by trade friction and the political climate. The Chinese economy is expected to improve, due in part to various government policies which will underpin growth. Although a continued rebound in the Japanese economy is expected as employment and ncome environment continues to improve and also due to support from various government policies, we need to keep a cautious eye on the impact that a downswing in the global economy would have.

Under these conditions, the Nippon Kayaku Group aims to construct a solid financial structure which flexibly
adapts to changes in the business environment, as well as expand existing businesses in global growth markets,
accelerate the development of new businesses and new products, and enhance profits.

The business results forecasts for fiscal year ending March 31, 2020 have been revised from the forecasts
announced on May 10, 2019. See the Notice of Revision to the Business Results Forecasts posted on the corporate
website today for further details

On November 12, 2019 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease, reported financial results for the third quarter ended September 30, 2019 (Press release, Akebia, NOV 12, 2019, View Source [SID1234550943]). The Company will host a conference call today, Tuesday, November 12, 2019, at 9:00 a.m. Eastern Time to discuss its third quarter 2019 financial results and recent business highlights.

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Akebia also announced that it has entered into a $100 million non-dilutive, definitive term loan agreement with funds managed by Pharmakon Advisors LP, the investment manager of the BioPharma Credit funds. The loans provide Akebia with up to $100 million of borrowing capacity available in two tranches. Subject to the satisfaction of customary conditions, Akebia expects to draw $80 million at an initial closing later this month, and an additional tranche of $20 million is available for draw at Akebia’s option until December 31, 2020. Additional information on the loan agreement will be included in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2019 that is expected to be filed with the U.S. Securities and Exchange Commission today, November 12, 2019.

"Akebia continues to make great progress advancing our strategy. We achieved a primary objective of the Company by strengthening our balance sheet with $80 to $100 million non-dilutive, tranched term loans, on very competitive terms, to further support our clinical development program for vadadustat, our investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) for the treatment of anemia due to chronic kidney disease (CKD), and other strategic goals. Importantly, we believe these loans, the first tranche of which is expected to close later this month, in combination with our other cash resources, are expected to extend our cash runway into 2021, well past our expected top-line data readouts of our global Phase 3 clinical studies of vadadustat. Auryxia product revenue allows us to service the debt," stated John P. Butler, Chief Executive Officer of Akebia. "As we believe we are now within two quarters of our first readout of our global Phase 3 studies of vadadustat with top-line data of INNO2VATE on track for Q2’FY20 and PRO2TECT for mid-2020, subject to the accrual of major adverse cardiovascular events (MACE), we’re working to sharpen the timelines for completion and keying in on NDA and MAA related activities and commercial plans for vadadustat, upon approval."

Butler continued, "We have a tremendous amount of confidence in the program that we’ve designed for vadadustat and believe we are positioned well for clinical, regulatory and commercial success. We expect vadadustat to be the first drug of the HIF class to deliver clear data that directly compares its outcomes to the current standard of care in both dialysis and non-dialysis patients for the treatment of anemia due to CKD. We believe these data will be highly informative for physicians, patients and payers as they make important decisions about patient care, and a key consideration when differentiating between HIFs in the class."

Recent Highlights

Auryxia (ferric citrate) net product revenue increased 13 percent year-over-year to $30.0 million for the third quarter of 2019. Total Auryxia prescriptions increased 15.5 percent year-over-year to 51,700 in the third quarter of 2019.

In November, Mitsubishi Tanabe Pharma Corporation (MTPC), Akebia’s development and commercialization collaboration partner in Japan for vadadustat, presented positive 24-week and 52-week data from two Phase 3 active-controlled pivotal studies evaluating the efficacy and safety of vadadustat in Japanese patients with anemia due to CKD, at the American Society of Nephrology (ASN) Kidney Week 2019. Each study met its primary endpoint based on mean hemoglobin level at week 20 and 24, and showed vadadustat’s effect on hemoglobin was sustained through to 52 weeks in each study. (See recent related press release here.) In July, MTPC submitted a Japanese New Drug Application (JNDA) to the Ministry of Health, Labor and Welfare in Japan for marketing approval of vadadustat as a treatment for anemia due to CKD. The JNDA is the first regulatory submission for marketing approval of vadadustat and, if approved, is expected to lead to the first launch of vadadustat worldwide, next year.

Nine abstracts, including several associated with vadadustat and Auryxia, Akebia’s FDA-approved drug, were presented at ASN in November.

In October, the Independent Data Monitoring Committee reviewed unblinded safety and efficacy data from Akebia’s global Phase 3 studies of vadadustat, as planned, and recommended continuation of the studies without modifications.

In October, Akebia filed a complaint in federal district court against the Centers for Medicare & Medicaid Services (CMS) and the U.S. Department of Health and Human Services (HHS). The lawsuit challenges a September 2018 decision by CMS that rescinded Medicare Part D coverage of Auryxia, when used for the treatment of iron deficiency anemia (IDA) in adult patients with CKD not on dialysis. The legal action also seeks to reverse a related decision by CMS that imposed a prior authorization requirement for Auryxia when used for the control of serum phosphorus levels in adult patients with CKD on dialysis.

In April and August, Akebia completed enrollment in its global Phase 3 program, INNO2VATE and PRO2TECT, respectively, evaluating the safety and efficacy of vadadustat in dialysis-dependent and non-dialysis dependent CKD subjects with anemia due to CKD. The Company continues to expect to report top-line data from the INNO2VATE and PRO2TECT studies in Q2’FY20 and mid-2020, respectively, subject to the accrual of MACE.

Financial Results

Total revenue for the third quarter of 2019 was $92.0 million, compared to $53.2 million in the pre-merger third quarter of 2018.

Auryxia net product revenue for the third quarter of 2019 was $30.0 million, compared to $26.6 million, as reported by Keryx Biopharmaceuticals, Inc. (Keryx) prior to its merger with the Company, during the same period in 2018. This represents a 13 percent increase in net product revenue from the third quarter of 2018.

Collaboration and license revenue for the third quarter of 2019 was $62.0 million, compared with $53.2 million in the third quarter of 2018. The increase was primarily due to increased collaboration revenue of $6.8 million from Otsuka Pharmaceutical Co. Ltd (Otsuka). In accordance with the Company’s collaboration agreements, Otsuka began funding 80 percent of the development costs for vadadustat in the second quarter of 2019.

Cost of goods sold was $38.3 million for the third quarter of 2019, consisting of $11.2 million of costs associated with the manufacture of Auryxia and non-cash charges of $27.1 million related to the application of purchase accounting as a result of the merger with Keryx. These non-cash, merger-related charges include a $18.0 million inventory step-up charge and $9.1 million of amortization of intangibles.

Research and development expenses were $74.5 million for the third quarter of 2019 compared to $70.6 million for the third quarter of 2018. The increase was primarily attributable to an increase in headcount and other costs to support its research and development programs and clinical and preclinical activities. These increases were partially offset by a decrease in external costs related to PRO2TECT and INNO2VATE Phase 3 studies as they advance toward readout.

Selling, general and administrative expenses were $34.2 million for the third quarter of 2019 compared to $10.4 million for the third quarter of 2018. The increase was primarily attributable to commercialization costs associated with Auryxia, as there were no comparable commercialization costs in the third quarter of 2018.

The Company reported a net loss for the third quarter of 2019 of $54.6 million, or ($0.46) per share, as compared to a net loss of $26.0 million, or ($0.46) per share, for the third quarter of 2018. The Company’s net loss for the third quarter of 2019 includes the impact of non-cash charges of $27.1 million related to the application of purchase accounting as a result of the merger with Keryx, offset by an income tax benefit of $1.3 million.

The Company ended the quarter with cash, cash equivalents and available-for-sale securities of $145.6 million. "We are pleased to have further strengthened our balance sheet and extended our operating cash runway with our very recent non-dilutive, tranched term loans for up to $100 million, with the first $80 million tranche expected to close later this month. We expect these loans, coupled with the committed research and development funding from our collaborators and the receipt of a regulatory milestone from MTPC, assuming approval of vadadustat in Japan, to provide us with the cash resources to fund our current operating plan into Q1 of 2021," stated Jason A. Amello, Chief Financial Officer of Akebia.

Conference Call

Akebia will host a conference call today, Tuesday, November 12, 2019, at 9:00 a.m. Eastern Time to discuss its third quarter 2019 financial results and recent business updates. To listen to the conference call, please dial (877) 458-0977 (domestic) or (484) 653-6724 (international) using conference ID number 9996464. 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 18, 2019. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference ID number 9996464. An online archive of the conference call can be accessed via the Investors section of the Company’s website at View Source

On November 12, 2019 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported financial results for the third quarter ended September 30, 2019 and provided an update on its corporate activities and product pipeline (Press release, Crinetics Pharmaceuticals, NOV 12, 2019, View Source [SID1234550962]).

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"Crinetics has continued to make significant strides in the development of new therapeutics to treat patients suffering from rare endocrine diseases and endocrine-related tumors," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "Our ACROBAT clinical studies for patients with acromegaly are advancing as is our Phase 1 study for CRN01941 aimed at neuroendocrine tumors. Furthermore, we are excited with the progress we have made to develop novel therapies for patients suffering from Cushing’s disease and hyperinsulinism as we continue to steer these programs towards clinical development."

Third Quarter and Subsequent Highlights

Received final award of SBIR grant from NIH for congenital hyperinsulinism. In July 2019, Crinetics announced that it would receive up to approximately $0.9 million in continued funding under its Small Business Innovation Research (SBIR) grant from the National Institute of Diabetes and Digestive and Kidney diseases (NIDDK) of the National Institutes of Health (NIH). The funds are being used to support the ongoing research and development of Crinetics’ nonpeptide somatostatin agonists for congenital hyperinsulinemias (CHI).

Expanded board of directors. In July 2019, Crinetics appointed Stephanie S. Okey, M.S. to its board of directors as an independent board member. Ms. Okey brings extensive leadership and management experience having spent her career in senior commercial roles including, most recently, Head of North America and U.S. General Manager of Rare Diseases at Genzyme.

Third Quarter 2019 Financial Results

Research and development expenses were $11.8 million and $29.4 million for the three and nine months ended September 30, 2019, respectively, compared to $6.9 million and $16.8 million for the same periods in 2018. The increases were primarily attributable to development and manufacturing activities for CRN00808 and CRN01941 as well as the company’s preclinical programs and higher personnel costs.

General and administrative expenses were $3.9 million and $10.1 million for the three and nine months ended September 30, 2019, compared to $1.7 million and $4.1 million for the same periods in 2018. The increases were primarily due to costs to operate as a public company, as well as personnel costs to support the company’s growth.

Net loss for the three months ended September 30, 2019 was $14.4 million, compared to a net loss of $7.6 million for the same period in 2018. For the nine months ended September 30, 2019, the company’s net loss was $35.9 million compared to a net loss of $18.6 million for the nine months ended September 30, 2018.

Unrestricted cash, cash equivalents and investments totaled $131.7 million as of September 30, 2019, compared to $145.0 million as of June 30, 2019 and $163.9 million as of December 31, 2018. Crinetics expects that its cash, cash equivalents and investments will fund its current operating plan at least through the first half of 2021.

As of October 31, 2019, the company had 24,222,296 common shares outstanding.