On November 13, 2019 Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of cancer patients, reported financial results for the three and nine months ended September 30, 2019, and provides an update on its business progress (Press release, Biocept, NOV 13, 2019, View Source [SID1234551228]).

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"We continued to deliver strong growth during the third quarter of 2019 with revenues reaching a record $1.5 million, up 101% over the same period in the prior year and up 28% over the second quarter of this year," said Michael Nall, President and CEO of Biocept. "Our momentum was driven by a 66% year-over-year increase in the number of commercial samples received, as we focus on segments of the liquid biopsy market where our Target Selector technologies and testing platform can help the most patients, namely patients with lung, prostate and breast cancers. In addition, we continue to work to control expenses, which has moved us closer to gross margin positive. We are focused on continued growth in commercial volume and improvement in gross margin percent through operational efficiencies.

"Testing for lung cancer continued to be among the largest contributors to commercial volume due to the difficulties in securing lung tissue samples from this patient population," he added. "We also continue to gain traction in the uro-oncology market where our blood-based testing is used by urologists to monitor patients with rising prostate-specific antigen (PSA) levels as well as in the post-surgery setting to identify patients at risk for cancer recurrence. We are seeing increasing reorders from the physicians and practices who began using our Target Selector products earlier this year, while establishing relationships with additional urologists and urology practice groups during the third quarter. We expect continued growth in this business segment.

"Our Target Selector testing for breast cancer was also a key contributor to commercial volume growth during the quarter. Clinicians treating patients with breast cancer are utilizing our blood-based assays for initial profiling of biomarkers to ensure that critical biomarkers are not missed with the original tissue biopsy as well as to re-profile patients who have cancer recurrence in order to determine the most appropriate treatment plan for each patient," Nall said.

Review of Third Quarter and Recent Highlights

Commercial Agreements

Announced an agreement with Beacon Laboratory Benefit Solutions designating Biocept as a BeaconLBS Lab-of-Choice. Beacon Laboratory is a nationally recognized provider of laboratory benefit management technology solutions to U.S.-based health and managed care companies. This designation increases patient access to Biocept’s liquid biopsy testing platforms.
Regulatory Approval

Obtained CE IVD Marks for the CEE-Sure Blood Collection Tube and the CEE-Sure Sample Collection Shipping Kit in Europe. These CE Marks confirm that Biocept’s CEE-Sure products, which are specifically designed to collect and transport blood and other liquid biopsy specimens, meet the requirements of the European In-Vitro Diagnostic Devices Directive. This allows Biocept to commercialize its tubes and collection/shipping kits throughout the European Union and other CE Mark geographies.
Industry Conferences and Study Results

Announced the presentation of six posters at the 2019 Association for Molecular Pathology (AMP) Annual Meeting featuring clinical data highlighting Target Selector tests and kits. The content of these posters is expected to be published in a future issue of The Journal of Molecular Diagnostics.
Presented data at the 2019 IASLC World Conference on Lung Cancer highlighting the ability of Biocept’s circulating tumor DNA (ctDNA) assays to consistently detect actionable biomarkers from the blood of patients diagnosed with lung cancer at a mutant allele frequency as low as 0.01%. The poster featured clinical experience data from more than 1,400 blood samples drawn from patients diagnosed with non-small cell lung cancer, and collected and shipped using the Company’s CEE-Sure Blood Collection Tubes.
Peer-reviewed Journal Publications

Announced publication of an article in the peer-reviewed journal PLOS ONE featuring analytical validation results demonstrating the ultra-sensitive detection of Target Selector testing for EGFR, BRAF and KRAS mutations in plasma ctDNA. These tests can be performed in the Company’s CLIA laboratory with a commercial turnaround time of only three to four days.
Intellectual Property

Awarded U.S., Canadian and European patents covering antibody and microchannel technology and enhanced detection of cancer cells. These new patents further expand Biocept’s intellectual property estate for capturing and detecting rare cells of interest, including CTCs to aid in the management of patients with cancer.
Granted a South Korean patent covering the Target Selector oncogene mutation enrichment and detection platform for proprietary Switch-Blocker technology that is core to Target Selector assays for molecular analysis using real-time PCR, Sanger sequencing and next-generation sequencing.
Ended the period with 36 issued patents globally for Biocept’s highly sensitive method of detecting cancer biomarkers.
Third Quarter Financial Results

Revenues for the third quarter of 2019 were $1.5 million, a 101% increase from $762,000 for the third quarter of 2018. Revenues for the third quarter of 2019 included $1.4 million in commercial test revenue, $40,000 in development services test revenue and $60,000 in revenue for Target Selector RUO kits, which were commercially launched in early 2019, and CEE-Sure blood collection tubes. Revenues for the third quarter of 2018 included $698,000 in commercial test revenues and $64,000 in development services test revenues.

Biocept accessioned 1,189 commercial samples during the third quarter of 2019, a 66% increase from the 717 commercial samples accessioned during the third quarter of 2018. The Company accessioned 1,332 billable samples in the third quarter of 2019, a 52% increase from 878 billable samples for the third quarter of 2018.

Cost of revenues for the third quarter of 2019 was $2.8 million, compared with $2.5 million for the third quarter of 2018. Cost of revenues for the third quarter of 2019 increased 14% while volume increased by nearly 50% as the Company continued to leverage its fixed costs.

Research and development (R&D) expenses for the third quarter of 2019 were $1.2 million, compared with $1.1 million for the third quarter of 2018, with the increase primarily due to an increase in materials used for developing and validating new assays. General and administrative (G&A) expenses for the third quarter of 2019 were $1.7 million, a decrease from $1.8 million during the third quarter of 2018 as the Company continued its cost-containment program. Sales and marketing (S&M) expenses for the third quarter of 2019 were $1.5 million, compared with $1.4 million for the third quarter of 2018, with the increase primarily attributed to commissions paid for higher volume and revenue.

The third quarter of 2018 included a non-cash deemed dividend of $0.6 million for the repricing of adjustable warrants. There was no comparable charge in the third quarter of 2019.

The net loss attributable to common shareholders for the third quarter of 2019 was $5.7 million, or $0.25 per share on 23.0 million weighted-average shares outstanding. The net loss attributable to common shareholders for the third quarter of 2018 was $6.7 million, or $2.42 per share on 2.8 million weighted-average shares outstanding. The Company completed a 1-for-30 reverse stock split of its common stock in July 2018.

Nine Month Financial Results

Revenues for the first nine months of 2019 were $3.7 million, a 57% increase from $2.4 million for the first nine months of 2018, and included $3.5 million in commercial test revenues, $130,000 in development services test revenues, and $90,000 in revenues for Target Selector RUO kits and CEE-Sure blood collection tubes.

Total costs and expenses for the first nine months of 2019 were $21.2 million, and included cost of revenues of $8.1 million, R&D expenses of $3.5 million, G&A expenses of $5.1 million and S&M expenses of $4.5 million.

Other expense for the first nine months of 2019 of $2.0 million consisted of non-cash warrant inducement expenses associated with recognizing the fair value of the inducement warrants issued in May 2019 of $1.8 million and $190,000 of interest expense. This compares with other expense of $240,000 for the first nine months of 2018 related to interest expense. The nine months ended September 30, 2019 included a non-cash deemed dividend of $0.1 million for the repricing of adjustable warrants, compared with a non-cash deemed dividend of $0.6 million for the repricing of adjustable warrants during the nine months ended September 30, 2018.

The net loss attributable to common shareholders for the first nine months of 2019 was $19.5 million, or $1.10 per share on 17.8 million weighted-average shares outstanding. This compares with a net loss attributable to common shareholders for the first nine months of 2018 of $19.2 million, or $8.26 per share on 2.3 million weighted-average shares outstanding. The Company completed a 1-for-30 reverse stock split of its common stock in July 2018.

Biocept reported cash and cash equivalents as of September 30, 2019 of $6.5 million, compared with $3.4 million as of December 31, 2018. The increase was due to $17.0 million in net proceeds from equity capital raises conducted in the first quarter of 2019, and $4.9 million from the exercise of common stock warrants exercised year-to-date in 2019.

Conference Call and Webcast

Biocept will hold a conference call today at 4:30 p.m. Eastern time to discuss these results and answer questions. The conference call can be accessed by dialing (855) 656-0927 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4109 for other international callers. A live webcast of the conference call will be available on the investor relations page of the company’s website at http://ir.biocept.com/events.cfm. A replay of the webcast will be available for 90 days.

A replay of the call will be available for 48 hours following its conclusion and can be accessed by dialing (877) 344-7529 for domestic callers, (855) 669-9658 for Canadian callers or (412) 317-0088 for other international callers. Please use event passcode 10135501.

On November 13, 2019 Reata Pharmaceuticals, Inc. (Nasdaq:RETA) ("Reata" or the "Company"), a clinical-stage biopharmaceutical company, reported the pricing of an underwritten public offering of 2,400,000 shares of its Class A common stock at a price to the public of $183.00 per share (Press release, Reata Pharmaceuticals, NOV 13, 2019, View Source [SID1234551306]). The offering was upsized to 2,400,000 shares from the original offering size of 2,000,000 shares. The gross proceeds to Reata from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be $439,200,000. The offering is expected to close on November 18, 2019, subject to customary closing conditions. In addition, Reata has granted the underwriters a 30-day option to purchase up to an additional 360,000 shares of Reata’s Class A common stock on the same terms and conditions.

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Citigroup, Jefferies, SVB Leerink and Stifel are acting as the joint book-running managers for the offering. Baird, Cantor and Ladenburg Thalmann are acting as co-managers for the offering.

Reata intends to use the net proceeds from the offering for working capital and general corporate purposes, which include, but are not limited to, advancing the development of bardoxolone methyl and omaveloxolone through clinical trials, preparing to file New Drug Applications for bardoxolone for the treatment of patients with Alport syndrome and omaveloxolone for the treatment of patients with Friedreich’s ataxia, planning for commercialization of its potential products, and making payments due under its agreement with AbbVie Inc.

The securities described above are being offered pursuant to an effective shelf registration statement on Form S-3. The offering may be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the Securities and Exchange Commission (the "SEC") and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus, when available, may also be obtained by request at Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 (Tel: 800-831-9146); at Jefferies, Attention: Equity Syndicate Prospectus Departments, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by phone at (877) 821-7388, or by email at [email protected]; at SVB Leerink, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6132, or by email at [email protected]; or Stifel, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, or by telephone at (415) 364-2720, or by email at [email protected].

This news release is for informational purposes only and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation, or sale of these securities would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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.