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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We 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 Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of targeted immunotherapies using fully human monoclonal antibodies (mAbs) to treat life-threatening bacterial infections, reported financial and corporate results for the third quarter ended September 30, 2019 (Press release, Aridis Pharmaceuticals, NOV 13, 2019, View Source [SID1234551227]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Third Quarter Highlights and Recent Developments

Advanced Phase 3 global clinical trial of AR-301 in patients with ventilator associated pneumonia (VAP) and remain on track to announce top line data expected in early 2021.
Executed an equity purchase agreement with Serum Institute BV (SIBV), an affiliate of the Serum Institute of India, Ltd. (SIIL), whereby SIBV invested $10 million into Aridis.
Executed license agreement with Serum AMR (SAMR), another affiliate of SIIL, for rights to multiple products and utilization of MabIgX platform technology (transaction included a $15M upfront payment).
Received Orphan Drug Designation (ODD) from The European Medicines Agency (EMA) for AR-501, an inhalable therapy for the treatment of chronic lung infections in cystic fibrosis patients.
Continued enrolling AR-501’s Phase 1/2a clinical trial with top-line data expected in Q1 2020 (healthy subjects), and in Q2 2021 (cystic fibrosis subjects).
Enhanced leadership team with key appointments including infectious disease expert, Dr. Paul Mendelman as Interim Chief Medical Officer.
Presented posters at the Infectious Disease Society of America’s (IDSA) IDWeek 2019 on AR-105 and AR-501.
Announced results from AR-105’s global Phase 2 clinical trial for the treatment of VAP caused by Pseudomonas aeruginosa (P. aeruginosa).
"The major emphasis for the period was laying the foundation for our long-term growth strategy as we head into the final quarter of 2019, and the new year. While we are certainly disappointed by AR-105’s Phase 2 clinical trial result, our intense post-data analysis gives us conviction that the ongoing phase 3 study for AR-301 in S. aureus VAP is being conducted with utmost rigor and scrutiny incorporating lessons learned from AR-105 to bring this drug to market. Similarly, we remain confident in the design and execution of the ongoing phase 1/ 2 trial for AR-501 targeting infections in cystic fibrosis patients," commented Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals.

"I’m especially pleased with the recent addition to management of Dr. Paul Mendelman who brings renowned infectious disease expertise to the team and is already impacting the data analysis of the AR-105 clinical trial as well as management of our ongoing Phase 3 clinical trial for AR-301 and Phase 1/2a clinical trial for AR-501 programs. Moving forward, we are now well positioned to execute on our clinical development strategy and to commence in earnest corporate development activities for the MabIgX platform," continued Dr. Truong.

Clinical Program Update

AR-301: During the third quarter, Aridis continued enrolling its Phase 3 global clinical trial for AR-301, which targets gram-positive S. aureus in critically ill VAP patients. The trial, which was initiated in the first quarter of 2019, is expected to enroll 240 patients at approximately 125 clinical centers in 20 countries. Interim data is expected in early 2020 and top line data is expected in early 2021. Participating centers in all countries are following the same stringent clinical protocols and procedures for critically ill VAP patients, as is standard in the U.S. and Europe. The trial represents the first ever Phase 3 superiority clinical study evaluating immunotherapy with a fully human monoclonal antibody to treat acute pneumonia in the intensive care unit setting. Details of the study can be viewed on www.clinicaltrials.gov using identifier NCT03816956.

AR-301 is a fully human monoclonal IgG1 antibody specifically targeting gram-positive S. aureus alpha-toxin. It has been shown in vitro to protect against alpha-toxin mediated destruction of host cells, thereby potentially preserving the human immune response. AR-301’s mode of action is independent of the antibiotic resistance profile of S. aureus and it is active against infections caused by both MRSA (methicillin resistant S. aureus) and MSSA (methicillin sensitive S. aureus).

AR-501: During the third quarter, Aridis continued enrolling patients in its Phase 1/2a clinical trial of this inhalable formulation of gallium citrate being evaluated for the treatment of chronic lung infections associated with cystic fibrosis. The single ascending dose cohorts of healthy subjects have completed dosing and the safety monitoring committee has recommended proceeding into the multiple ascending dose cohorts. The Company expects to report data from the Phase 1 portion of the trial which consists of healthy subjects in Q1 2020 and the Phase 2a segment with cystic fibrosis subjects in Q2 2021.

AR-501, which is being developed in collaboration with the Cystic Fibrosis Foundation (CFF), has been granted by the U.S. Food and Drug Administration (FDA) both Fast Track and Qualified Infectious Disease Product Designation (QIDP) designations. In addition, during the third quarter (July 19th), the EMA granted the program Orphan Drug Designation (ODD). The FDA had granted ODD status to AR-501 in June 2019.

Details of the Phase 1/2a clinical trial, which is a randomized, double-blinded, placebo controlled single and multiple dose-ascending trial investigating the safety and pharmacokinetics of inhaled AR-501 in healthy volunteers and cystic fibrosis patients with chronic bacterial lung infections, can be viewed on www.clinicaltrials.gov using identifier NCT03669614. The study is expected to accrue 48 healthy adult volunteers and 48 cystic fibrosis patients from approximately 15 sites in the U.S.

AR-105: During the third quarter (September 3, 2019), Aridis reported results for its global Phase 2 clinical trial evaluating AR-105, a fully human IgG1 monoclonal antibody for the treatment of VAP caused by gram-negative Pseudomonas aeruginosa (P. aeruginosa). The completed study did not meet its primary endpoint of demonstrating superiority in clinical cure rates on Day 21 compared to placebo. Furthermore, there was a statistically significant imbalance in all-cause mortality, as well as serious adverse event (SAE) rates between treatment groups that favored placebo. However, no SAE or mortality in the study was deemed to be drug related by the study investigators or the study’s data monitoring committee. AR-105 has a different mechanism of action, directed at a different bacterium, and evaluated in a different patient population as compared to AR-301. While no further development resources will be allocated towards AR-105, the Company will continue to analyze the full data set to better understand the top-line results.

Throughout the third quarter, Aridis continued to attend investor and medical conferences and recently presented two posters at the Infectious Disease Society of America’s (IDSA) IDWeek 2019, which took place on October 2nd-6th in Washington, DC. Both posters, "Pre-Clinical and Phase I Safety Data for Anti-Pseudomonas aeruginosa Human Monoclonal Antibody AR-105," and "In Vitro and In Vivo Non Clinical Efficacy of AR-501 (Gallium Citrate)," were presented on October 3, 2019.

Infectious Disease Specialist CMO Appointment: A recent key highlight occurred on October 11, 2019, when Aridis announced the appointment of Paul Mendelman, MD, as interim Chief Medical Officer, replacing Dr. Wolfgang Dummer who departed the company for personal reasons. Dr. Mendelman brings to Aridis a prolific career in infectious diseases across industry and academia spanning over 30 years with board certification in pediatrics and pediatric infectious diseases. He has held senior clinical development positions at leading companies such as Takeda Vaccines (Vice President, Medical), MedImmune (Vice President & Therapeutic Area Leader, Clinical Development), and Merck (Director, Clinical Research Infectious Diseases). From 1996 to 2005, he managed the clinical development group for FluMist, the live attenuated intranasal influenza vaccine, licensed initially in the U.S. for the 2003-04 season. The Company also promoted Lynne Deans to the position of Vice President, Clinical Operations. Ms. Deans has over 30 years of experience in clinical operations and has held senior director of clinical operations positions in infectious diseases focused companies such as Cerexa, PaxVax, and Kalobios.

Corporate Update:

A key highlight during the third quarter was the execution of a license agreement with SAMR, an affiliate of SIIL. The agreement provides SAMR with the right to in-license Aridis’ clinical stage programs AR-301(VAP), AR-105 (VAP) and AR-101 (hospital acquired pneumonia (HAP)). These license rights will be exclusive and to a limited territory which includes markets outside of the U.S., Europe, Canada, UK, China, Australia, New Zealand and Japan. Also, the agreement includes an exclusive, worldwide license (excluding China) to AR-201, a preclinical fully human mAb for the prevention of respiratory syncytial virus (RSV). In addition, SAMR may elect to collaborate with Aridis to utilize MabIgX to identify and advance up to five SAMR wholly-owned programs. MabIgX is Aridis’ proprietary technology platform to rapidly identify rare, potent antibody-producing B-cells from patients who have successfully overcome an infection to produce mAbs.

Under the terms of the Agreement, Aridis received a $15M upfront payment and will be eligible to receive as much as $42.5 million in future milestone payments for achieving product development and commercial objectives, along with royalties on net sales. The consummation of this transaction follows an equity purchase agreement with SIBV, another affiliate of SIIL, which occurred in July 2019 whereby SIBV invested $10 million into Aridis.

"We continued to make major strides in corporate development with a key pharmaceutical alliance, which also improves our balance sheet. SIIL is the world’s largest vaccine manufacturer by dose units and a significant monoclonal antibody development and manufacturing company. This combined product and technology license is a testament to the quality of our pipeline and groundbreaking MabIgX platform for identifying rare, potent antibody-producing B-cells from patients who have successfully overcome an infection to produce mAbs," concluded Dr. Truong.

Fiscal 2019 Third Quarter Results:

Cash: Total cash and cash equivalents as of September 30, 2019 was $17.3 million. In addition, in October 2019 the Company received $10 million, the balance due on the upfront payment from SAMR upon the execution of license agreement referred to above.
Revenues: Total revenues for the quarter ended September 2019 was zero, a decrease of $1.0 million over the same period in 2018 when a $1.0 million milestone payment was recognized from the CFF associated with its grant to fund the AR-501 Phase 1/2a clinical trial.
Research and Development Expenses: Research and development expenses for the quarter ended September 30, 2019 were $6.0 million, a decrease of $0.9 million over the same period in 2018 due primarily to a decrease in spending on clinical trial activities and drug manufacturing for our AR-105 program, which was recently completed, partially offset by an increase in spending on clinical trial activities for both our AR-301 Phase 3 and the AR-501 Phase 1/2a programs.
General and Administrative Expenses: General and administrative expenses for the quarter ended September 30, 2019 were $1.4 million, an increase of $0.6 million over the same period in 2018 due primarily to an increase in personnel related expenses, including stock-based compensation, an increase in patent related fees and an increase in directors’ and officers’ liabilities insurance expense.
Interest and Other Income, net: Interest and other income, net for the quarter ended September 30, 2019 was $90,000, a decrease of $29,000 over the same period in 2018. This decrease was due primarily to a lower average cash balance.
Change in Fair Value of Warrant Liability: As a result of all warrants to purchase preferred stock being converted into warrants to purchase common stock upon our IPO in August 2018, there was no warrant liability recorded at the end of the third quarter of 2019. There was a $1.4 million loss attributed to an increase in the fair value of the warrant liability in the third quarter of 2018.
Net Loss: The net loss available to common shareholders for the quarter ended September 30, 2019 was $7.6 million, or ($0.87) per share, compared to a net loss available to common shareholders of $7.9 million, or ($1.97) per share, for the quarter ended September 30, 2018. It should be noted that there were 166,373 common shares outstanding during the third quarter of 2018 and until the completion of the Company’s IPO in August 2018. Moreover, there were convertible preferred shares outstanding until the time of the IPO which earned dividends that were distributed as additional shares of preferred stock. All preferred shares were converted to common stock upon the completion of the IPO on August 16, 2018. As a result, the weighted average common shares outstanding for the third quarter of 2018 was 4.0 million. At September 30, 2019, the weighted average common shares outstanding for the third quarter of 2019 was 8.7 million.

On November 13, 2019 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("Company"), a pre-clinical stage biotechnology company specializing in the development of novel treatments for brain tumors, reported the closing of its initial public offering of 2,125,000 shares of common stock at an initial public offering price of $4.00 per share (Press release, CNS Pharmaceuticals, NOV 13, 2019, View Source [SID1234551226]). The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by the Company, were $8.5 million. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 318,750 shares of common stock at the initial price to the public less underwriting discounts and commissions. The Company’s common stock is listed on the NASDAQ Capital Market under the symbol CNSP.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Benchmark Company, LLC acted as sole Book Running Manager for the offering.

A registration statement on Form S-1 (File No. 333-232443) relating to the shares was filed with the Securities and Exchange Commission ("SEC") and became effective on November 7, 2019. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from The Benchmark Company, LLC, Attn: Prospectus Department, 150 E 58th Street, 17th floor, New York, NY 10155, 212-312-6700, Email: [email protected].

This press release shall not constitute an offer to sell or a 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 would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Berubicin
Berubicin is an anthracycline, a class of drugs among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to damage the DNA of targeted cancer cells by interfering with the action of the topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin was developed at the MD Anderson Cancer Center (MDACC), the world’s largest cancer research facility. Berubicin appeared to demonstrate one Durable Complete Response in a Phase I human clinical trial conducted by a prior developer.

On November 13, 2019 China Biologic Products Holdings, Inc. (NASDAQ: CBPO, "China Biologic" or the "Company"), a leading fully integrated plasma-based biopharmaceutical company in China, reported its unaudited financial results for the third quarter of 2019 (Press release, China Biologic Products, NOV 13, 2019, View Source [SID1234551225]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Third Quarter 2019 Financial Highlights

Total sales in the third quarter of 2019 increased by 17.5% in RMB terms and 14.3% in USD terms to $136.1 million from $119.1 million in the same quarter of 2018.
Gross profit increased by 9.1% to $88.6 million from $81.2 million in the same quarter of 2018. Gross margin decreased to 65.1% from 68.2% in the same quarter of 2018.
Income from operations increased by 84.7% to $53.0 million from $28.7 million in the same quarter of 2018. Operating margin increased to 38.9% from 24.1% in the same quarter of 2018.
Non-GAAP adjusted income from operations increased by 64.1% in RMB terms and 59.7% in USD terms to $61.5 million from $38.5 million in the same quarter of 2018.
Net income attributable to the Company increased by 42.9% to $47.0 million from $32.9 million in the same quarter of 2018. Diluted net earnings per share increased to $1.21 compared to $0.94 in the same quarter of 2018.
Non-GAAP adjusted net income attributable to the Company increased by 66.0% in RMB terms and 61.4% in USD terms to $54.4 million from $33.7 million in the same quarter of 2018. Non-GAAP adjusted net earnings per diluted share increased to $1.40 from $0.96 in the same quarter of 2018.
NOTE: Detailed financial statements and information are available through this link: View Source

"We were pleased to achieve another quarter of strong financial results, driven primarily by the higher-than-expected IVIG sales in the distributor channel following the successful reorganization of our sales and marketing team," said Joseph Chow, Chairman and CEO of China Biologic. "Looking into the fourth quarter and beyond, our new sales and marketing talent will be dedicated to the further pursuit of medical marketing strategies to enhance doctors’ awareness about the benefits of IVIG, PCC, and other coagulation factor products in treating chronic diseases. As a result of stronger than expected albumin sales for the first nine months of the year combined with this quarter’s rebound in IVIG sales, we are raising guidance for the full year 2019."

Financial Outlook

For the full year of 2019, the Company is raising its full year forecast of growth of non-GAAP adjusted income from operations to 11% to 13% from 4% to 6% and non-GAAP adjusted net income growth to 16% to 18% from 4% to 6% in RMB terms over the Company’s full year 2018 financial results. The raising of guidance was primarily due to the combined effect of stronger than expected albumin sales for the first nine months of the year, a rebound in IVIG sales in the third quarter, and higher than anticipated interest income for the full year.

This guidance does not factor in any potential foreign currency translation impact. Having previously adopted an exchange rate of approximately RMB6.59 = $1.00 based on weighted average quarterly exchange rates in 2018 in translating 2018 financial results, the Company expects that the total sales and non-GAAP adjusted net income in USD terms in 2019 could be affected by the foreign currency translation impact.

This guidance excludes potential acquisitions, and necessarily assumes no significant adverse product price changes during 2019. This forecast reflects the Company’s current and preliminary views, which are subject to change.

Conference Call

The Company will host a conference call at 7:30 am Eastern Time on Thursday, November 14, 2019, which is 8:30 pm Beijing Time on November 14, 2019, to discuss its third quarter 2019 results and answer questions from investors. Listeners may access the call by dialing:

US:

1 888 346 8982

International:

1 412 902 4272

Hong Kong:

800 905 945

Mainland China:

400 120 1203

A telephone replay will be available one hour after the conclusion of the conference all through November 21, 2019. The dial-in details are:

US:

1 877 344 7529

International:

1 412 317 0088

Passcode:

10136730

A live and archived webcast of the conference call will be available through the Company’s investor relations website at View Source

On November 13, 2019 Nektar Therapeutics’ (Nasdaq: NKTR) senior management is reported to present at the upcoming Jefferies 2019 Healthcare Conference in London on Wednesday, November 20, 2019 at 4:00 p.m. Greenwich Mean Time (Press release, Nektar Therapeutics, NOV 13, 2019, View Source [SID1234551224]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The presentation will be accessible via a Webcast through a link posted on the Investor Events section of the Nektar website: View Source This Webcast will be available for replay until December 12, 2019.