On August 3, 2018 Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company focused on identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology and immunology, reported financial results for the second quarter of 2018 and provided an update on its clinical development and commercial programs (Press release, Aclaris Therapeutics, AUG 3, 2018, View Source [SID1234528426]).

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During the second quarter of 2018 Aclaris launched ESKATA (hydrogen peroxide) Topical Solution, 40% (w/w), recording $1.5 million in net product sales.
In July, Aclaris held an end of Phase 2 meeting with the FDA regarding A-101 45% Topical Solution (A-101 45%) for the treatment of common warts (verruca vulgaris) and is on track to start its planned Phase 3 program in the second half of 2018.
Aclaris is seeing encouraging results which validate the topical approach in the ongoing open label studies of its topical Janus kinase (JAK) inhibitor ATI-502 in patients with Alopecia Areata (AA) and the more severe and refractory phenotypes – Alopecia Totalis (AT) and Alopecia Universalis (AU).
Aclaris remains confident in the ongoing AA-201 Topical trial of ATI-502 in patients with the less severe phenotype of patchy AA, data from which is expected in the first half of 2019.
Aclaris recently started a Phase 2 clinical trial of its investigational JAK inhibitor ATI-501 oral suspension in patients with AA, including AT and AU.
"The second quarter represents an important milestone with the launch of ESKATA. This is an exciting time for Aclaris as we establish ourselves as a fully integrated commercial organization with a robust clinical-stage pipeline and drug discovery engine," said Dr. Neal Walker, President and Chief Executive Officer of Aclaris.

Commercial Update:

Sales Force Activity:

Sales force focused on driving clinical and business integration in ESKATA accounts; ongoing in-service programs to support successful training and product integration.
Over 800 ESKATA accounts opened to date
Over 40 ESKATA peer-to-peer speaker programs conducted to date
ESKATA Campaign Highlights:

ESKATA branded HCP journal ads introduced in major dermatology journals
Supported 30 conferences in the second quarter of 2018.
Continued positive feedback from ESKATA Early Experience Initiative (EEI) captured in physician and patient post-application surveys.
Clinical Pipeline Update:

A-101 45% Topical Solution
Completed an End of Phase 2 meeting with the FDA in July and plan to initiate a Phase 3 program for the treatment of common warts in the second half of 2018.

JAK Inhibitor Trials:
AA-202 Topical –
An ongoing Phase 2 clinical trial of ATI-502 for the topical treatment of AA. Recently reported interim pharmacokinetic and pharmacodynamic results for 6 of the 11 enrolled patients; two patients have withdrawn.
After completing the 28-day portion of the trial, patients entered a 6-month open label extension during which all patients will receive drug.
Demonstrated drug levels in skin and pharmacodynamic effect as measured by RNA sequencing.
Evidence of hair regrowth in the open label extension portion of this study has been observed.
Safety results – generally well-tolerated; no treatment related serious adverse events reported to date.
The range of time on drug for the nine patients in the open label extension is 6 to 20 weeks.
AUATB-201 Topical – an ongoing Phase 2 open-label clinical trial of ATI-502 for the topical treatment of AA in Australia. In this trial Aclaris is evaluating the efficacy of ATI-502 on the regrowth of eyebrows in patients with AA, including AT and AU. Interim update:
12 patients enrolled; 2 patients have withdrawn.
Evidence of early signs of hair regrowth has been observed.
Safety results – generally well-tolerated; no treatment-related serious adverse events reported to date.
The range of time on drug for the 10 patients is 5 to 23 weeks.
AA-201 Topical – an ongoing Phase 2 dose ranging trial of ATI-502 for the topical treatment of AA. This trial will evaluate the efficacy of two concentrations of ATI-502 on the regrowth of hair in a randomized, double-blinded, parallel-group, vehicle-controlled trial in up to 120 patients with AA. This trial is being conducted in the United States and data are expected in the first half of 2019.

VITI-201 Topical – an ongoing Phase 2 open-label clinical trial of ATI-502 for the topical treatment of vitiligo. This trial will evaluate the efficacy of ATI-502 on the repigmentation of facial skin in up to 24 patients with vitiligo and data are expected in the first half of 2019.

AGA-201 Topical – an ongoing Phase 2 open-label clinical trial of ATI-502 for the topical treatment of androgenetic alopecia (AGA), also known as male/female pattern hair loss. This trial will evaluate the efficacy of ATI-502 on the regrowth of hair in up to 24 patients with AGA and data are expected in the first half of 2019.
AUAT-201 Oral – an ongoing Phase 2 dose ranging trial of ATI-501, an oral JAK inhibitor for the treatment of AA. This trial will evaluate the efficacy of two concentrations of ATI-501 on the regrowth of hair in a randomized, double-blinded, parallel-group, vehicle-controlled trial in up to 80 patients with AA. This trial will be conducted in the United States and data are expected in the second half of 2019.

AD-201 Topical – the first patient has been dosed in an ongoing Phase 2 clinical trial of ATI-502 in patients with atopic dermatitis (AD). This open label trial will evaluate the safety, tolerability and efficacy of ATI-502 applied twice daily to affected skin for four weeks in up to 30 adult subjects with moderate-to-severe AD. This trial will be conducted in the United States and data are expected in mid-2019.

ATI-450 (MK-2 Inhibitor)
Investigational New Drug application on track for submission to the FDA in mid-2019.
Recent Corporate Highlights

Presented at the recent American Hair Research Society (AHRS) and International Investigative Dermatology (IID) meetings.
United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 9,980,983 covering methods of treating seborrheic keratosis using a stabilized hydrogen peroxide composition. This patent is listed in the Orange Book for ESKATA and is set to expire in April 2035, subject to any patent term adjustment or extension.
Received Fast Track designation for ATI-502 for the treatment of AA, including patchy AA, AT and AU.
Appointed David Gordon, MB, ChB, as Chief Medical Officer.
Financial Highlights

Second Quarter 2018 Financial Results

For the quarter ended June 30, 2018, total net revenues were $3.7 million, which consisted of ESKATA sales of $1.5 million, contract research revenues of $1.1 million, and other revenue of $1.0 million. For the six months ended June 30, 2018, total net revenues were $4.8 million, which consisted of ESKATA sales of $1.5 million, contract research revenues of $2.3 million, and other revenue of $1.0 million. Cost of revenues for the quarter and six months ended June 30, 2018 were $1.2 million and $2.1 million, respectively. There were no revenues or cost of revenues in either prior year period.

For the quarter ended June 30, 2018, total operating expenses were $34.5 million, compared to $15.3 million for the second quarter of 2017. For the six months ended June 30, 2018, total operating expenses were $65.6 million, compared to $28.2 million for the same period in 2017.
Research and development (R&D) expenses for the quarter and six months ended June 30, 2018 were $14.0 million and $27.6 million, respectively, compared to $8.0 million and $15.7 million, respectively, for the same periods of 2017. The increases of $6.0 million and $11.9 million, respectively, were mainly the result of the expansion of Aclaris’ JAK inhibitor programs, as multiple Phase 2 trials of ATI-501 and ATI-502 are ongoing in 2018, as well as medical affairs activities and drug discovery programs, both of which were not incurred in 2017. Personnel related expenses, including stock-based compensation, also increased due to increased headcount to support these programs and as the result of the acquisition of Confluence in August 2017.

Sales and marketing (S&M) expenses for the quarter and six months ended June 30, 2018 were $12.4 million and $23.6 million, respectively, compared to $2.2 million and $3.6 million, respectively, for the same periods of 2017. The increases of $10.2 million and $20.0 million, respectively, were mainly the result of increases in direct marketing and professional fees, as well as other commercial expenses incurred in preparation for the launch of ESKATA, which occurred in May 2018. Personnel expenses, including stock-based compensation, increased as Aclaris completed the hiring of its field sales force in the first quarter of 2018.

General and administrative (G&A) expenses for the quarter and six months ended June 30, 2018 were $8.1 million and $14.4 million, respectively, compared to $5.1 million and $8.9 million, respectively, for the same periods of 2017. The increases of $3.0 million and $5.5 million, respectively, were mainly the result of higher personnel-related expenses, including stock-based compensation, due to increased headcount to support the commercial launch of ESKATA, and as the result of the acquisition of Confluence in August 2017. G&A expenses for the quarter and six months ended June 30, 2018 also included a $1.5 million payment based on an ESKATA-related milestone, whereas the quarter and six months ended June 30, 2017 included a $1.0 million ESKATA-related milestone payment.

For the quarter ended June 30, 2018, net loss was $31.2 million, or $1.01 per basic and diluted share, as compared to $14.8 million, or $0.56 per basic and diluted share, for the second quarter of 2017. For the six months ended June 30, 2018, net loss was $61.4 million, or $1.99 per basic and diluted share, as compared to $27.4 million, or $1.04 per basic and diluted share, for the same period of 2017.
Liquidity and Capital Resources

As of June 30, 2018, Aclaris had aggregate cash, cash equivalents and marketable securities of $164.6 million compared to $208.9 million as of December 31, 2017.

Aclaris anticipates that its cash, cash equivalents and marketable securities as of June 30, 2018 will be sufficient to fund its operations into the second half of 2019, without giving effect to any potential new business development transactions or financing activities.

2018 Financial Outlook

Aclaris reiterated its expected 2018 GAAP R&D expenses to be in the range of $67 to $75 million, including estimated stock-based compensation of $9 million. The anticipated increase in R&D expenses in 2018 is mainly due to the planned execution of Phase 2 clinical trials in AA, AGA and vitiligo, two planned pivotal Phase 3 trials in common warts, and the development of Aclaris’ early stage pipeline compounds.

Aclaris reiterated its expected 2018 GAAP selling, general and administrative (SG&A) expenses, which combine its Sales & marketing, and General & administrative line items, to be in the range of $80 to $86 million, including estimated stock-based compensation of $14 million. The anticipated increase in SG&A expenses in 2018 is primarily the result of the deployment of Aclaris’ new sales force in January 2018 and the additional selling, marketing and consumer initiatives to support the commercial launch of ESKATA.

Company to Host Conference Call

Management will conduct a conference call at 8:00 AM ET today to discuss Aclaris’ financial results and provide a general business update. The conference call will be webcast live over the Internet and can be accessed by logging on to the "Investors" page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call.

To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 8189419 prior to the start of the call.

On August 3, 2018 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 second quarter of 2018 (Press release, China Biologic Products, AUG 3, 2018, View Source [SID1234528424]).

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Second Quarter 2018 Financial Highlights

Total sales in the second quarter of 2018 increased by 25.5% in RMB terms and 34.8% in USD terms to $120.4 million from $89.3 million in the same quarter of 2017.
Gross profit increased by 39.7% to $82.7 million from $59.2 million in the same quarter of 2017. Gross margin increased to 68.7% from 66.3% in the same quarter of 2017.
Income from operations decreased by 15.3% in RMB terms, and 8.9% in USD terms to $35.9 million from $39.4 million in the same quarter of 2017. Operating margin decreased to 29.8% from 44.1% in the same quarter of 2017. Excluding TianXinFu, income from operations decreased by 30.3% in RMB terms and 25.1% in USD terms in the second quarter of 2018 compared to the same quarter of 2017, and operating margin decreased to 27.5% from 44.1% in the same quarter of 2017.
Non-GAAP adjusted income from operations decreased by 3.7% in RMB terms and increased by 3.6% in USD terms to $49.2 million from $47.5 million in the same quarter of 2017. Excluding TianXinFu, non-GAAP adjusted income from operations decreased by 21.0% in RMB terms and 15.1% in USD terms in the second quarter of 2018 compared to the same quarter of 2017.
Net income attributable to the Company decreased by 14.1% in RMB terms and 7.7% in USD terms to $28.6 million from $31.0 million in the same quarter of 2017. Fully diluted earnings per share decreased by 23.9% to $0.83 compared to $1.09 in the same quarter of 2017. Excluding TianXinFu, net income attributable to the Company decreased by 29.7% in RMB terms and 24.2% in USD terms in the second quarter of 2018 compared to the same quarter of 2017.
Non-GAAP adjusted net income attributable to the Company decreased by 2.8% in RMB terms and increased by 4.4% in USD terms to $40.2 million from $38.5 million in the same quarter of 2017. Non-GAAP adjusted earnings per share decreased to $1.17 from $1.35 in the same quarter of 2017. Excluding TianXinFu, non-GAAP adjusted net income attributable to the Company decreased by 19.4% in RMB terms and 13.2% in USD terms in the second quarter of 2018 compared to the same quarter of 2017.
Certain income statement and balance sheet items impacted by the TianXinFu acquisition are presented for comparison purposes.
Mr. David Hui Li, Chairman of the Company, commented, " Our second quarter of 2018 continued to be challenging due to the ongoing impact of regulatory changes and intensified competition in China’s healthcare market. Because of spending controls by regional government-sponsored medical insurance programs, an increasing number of hospitals across various provinces are implementing stricter drug purchase budgets by capping drug revenue to no more than 30% of a hospital’s total revenue. This has led to another high-double-digit decline in our direct sales channel revenue in the second quarter. To offset this negative impact, the Company pursued new distributor and pharmacy channels. However, the intensified competition in the distribution market has caused over 10% year-over-year price declines across all major plasma products, deteriorated payment terms, and increased marketing expenditures. In addition, although our placenta polypeptide product experienced a 70% sales revenue growth in RMB terms, its sales volume declined over 30% due to the implementation of the two-invoice policy and the exclusion of it as a supplemental drug from the reimbursement lists of certain provinces. Our TianXinFu business performance met our expectations, and we remain conservatively optimistic about its growth in the second half of the year."

"Recently, the Board of Directors implemented certain important personnel changes. As previously disclosed, the Board removed David Gao as Chairman and director of the Board, and CEO and President of the Company. Subsequently, the Board also terminated David Gao’s employment for cause based on the Board’s review of the facts and circumstances of his removal. Concurrent to Mr. Gao’s removal, two other directors stepped down from the Board. The Board elected me as Chairman, and elected two industry veterans Mr. Qi Ning and Mr. Bing Li to the Board as independent directors. While the Board is conducting search for a new CEO, the Board has appointed Mr. Zhijun Tong as the acting CEO. Mr. Tong is an experienced entrepreneur and executive, and has been a director of the Company since 2012. The Board believes that the overhaul of the senior management and the changes at the Board level will greatly improve the Company’s governance and management and rejuvenate our business, particularly in today’s challenging environment."

Mr. Li continued, "In July, we received the operating permit for our new Feicheng branch plasma collection facility and commenced commercial operations immediately. We also recently extended our strategic collaboration agreement with Xinjiang Deyuan for another 3 years to purchase at least an additional 500 tonnes of plasma. We believe this extended collaboration is mutually beneficial, as it secures plasma supply to enhance our Guizhou facility’s utilization efficiency."

"For the second half of the year, we expect the regulatory headwinds and market competitive dynamics to persist, which will impact our guidance for the year. However, we remain optimistic about the mid- to long-term prospects of our industry, which we believe will continue to transit from a market of demand serving to demand creation in the next three to five years. Specifically, the industry growth engine will shift from albumin to IVIG and coagulation products, which have much higher margins and greater market potential. This transition will open many new opportunities for us and will take China’s plasma industry into the next development stage to replicate what happened in the U.S and Europe decades ago. Currently, due to limited awareness among Chinese doctors and medical practitioners, the growth of immunoglobulin products and high-end premium coagulation products have lagged behind that of albumin, and under-penetration of these products will persist in China’s markets. Our new Board leadership will support the executive management team to upgrade our commercial capabilities and to solidify our leading market position by expanding into new sales channels and by promoting our immunoglobulin and coagulation products. We will remain focused on improving per liter economics by leveraging our leading R&D capabilities to expedite the launch of new pipeline products. As always, we remain focused on pursuing long-term, sustainable growth and maximizing long-term shareholder value," concluded Mr. Li.

Second Quarter 2018 Financial Performance

Total sales in the second quarter of 2018 increased by 25.5% in RMB terms, or 34.8% in USD terms due to the benefit of favorable exchange rates, to $120.4 million from $89.3 million in the same quarter of 2017. The increase in total sales was partly attributable to a $13.0 million contribution from TianXinFu, which accounted for approximately 10.8% of total sales for the quarter. Excluding TianXinFu, total sales in the second quarter of 2018 increased by 11.9% in RMB terms, attributable to the sales increases in placenta polypeptide products, human albumin products, coagulation factor products, and certain immunoglobulin products, which was partly offset by the decrease in the sales of IVIG products. For plasma products, total sales in the second quarter of 2018 increased by 5.0% in RMB terms, or 12.7% in USD terms, to $90.3 million from $80.1 million in the same quarter of 2017.

During the second quarter of 2018, human albumin and IVIG products remained the Company’s two largest sales contributors. Revenue from human albumin increased by 9.6% in RMB terms, or 17.6% in USD terms, from $32.4 million in the second quarter of 2017 to $38.1 million in the second quarter of 2018. Revenue from IVIG products decreased by 11.8% in RMB terms, or 5.4% in USD terms, from $29.7 million in the second quarter of 2017 to $28.1 million in the second quarter of 2018. As a percentage of total sales, sales from human albumin and IVIG products were 31.7% and 23.4%, respectively, in the second quarter of 2018. Excluding the contribution from TianXinFu, human albumin and IVIG products represented 35.5% and 26.2% of total sales, respectively, compared to 36.3% and 33.3%, respectively, in the second quarter of 2017. The large decrease of IVIG sales’ percentage mainly reflected the combined effects of decreased sales volume and sales prices year over year.

The sales volume of human albumin products increased by 15.6% for the second quarter of 2018 compared to the same quarter of 2017, primarily due to increased sales volumes in the distributor and pharmacy channels, which was partly offset by decreased prescription volumes at various hospitals due to the ongoing healthcare regulatory changes in China. The sales volume of IVIG products decreased by 9.0% for the second quarter of 2018 compared to the same quarter of 2017, mainly reflecting decreased prescription volumes at various hospitals with the same effect of policy headwinds to human albumin.

The average prices for human albumin and IVIG products decreased by 5.2% and 3.1%, respectively, in RMB terms in the second quarter of 2018 compared to the same quarter of 2017 because of greater sales volume in the distributor channel and further price discounts to certain distributors reflecting intensified market competition for major plasma products. In USD terms, due to favorable exchange rates, the average price for human albumin and IVIG products increased by 1.9% and 4.1% year over year, respectively.

Revenue from specialty immunoglobulin products increased by 12.8% in RMB terms, or 21.2% in USD terms, in the second quarter of 2018 compared to the same quarter of 2017, reaching 12.8% of total sales. This increase was mainly due to higher sales volumes of human rabies immunoglobulin products and human tetanus immunoglobulin products.

Revenue from coagulation factor products, including human coagulation factor VIII, human prothrombin complex concentrate, and the newly launched human fibrinogen products, increased by 50.9% in RMB terms, or 62.3% in USD terms, in the second quarter of 2018 compared to the same quarter of 2017, representing 7.1% of total sales. The growth mainly came from the launch of our human fibrinogen products in the beginning of 2018 and the increased sales volumes of the Company’s human coagulation factor VIII and human prothrombin complex concentrate products, which is reflective of the Company’s ongoing medical marketing activities.

Revenue from placenta polypeptide products increased by 71.6% in RMB terms, or 84.4% in USD terms, in the second quarter of 2018 compared to the same quarter of 2017, reaching 14.1% of total sales, which was supported by higher unit selling prices in connection with the wider implementation of the two-invoice policy. However, the sales volume of placenta polypeptide products continued to decline as a result of their inclusion in regional supplemental drug lists, which put pressure on their prescription volume.

Cost of sales increased by 24.9% to $37.6 million in the second quarter of 2018 compared to the same quarter of 2017. As a percentage of total sales, cost of sales decreased to 31.2% from 33.7% in the same quarter of 2017. The decrease in cost of sales as a percentage of total sales mainly reflected the higher gross margin of TianXinFu. Excluding TianXinFu, cost of sales was 33.6% of total sales, remaining stable year over year, a net impact of a higher sales price for the Company’s placenta polypeptide product and lower sales prices for its human albumin and IVIG products.

Gross profit increased by 39.7% to $82.7 million in the second quarter of 2018 from $59.2 million in the same quarter of 2017. Gross margin was 68.7% and 66.3% in the second quarters of 2018 and 2017, respectively.

Total operating expenses in the second quarter of 2018 was $46.9 million compared to $19.8 million in the same quarter of 2017. As a percentage of total sales, total operating expenses increased to 39.0% in the second quarter of 2018 from 22.2% in the same quarter of 2017. Excluding TianXinFu, total operating expenses increased by $22.0 million, or 111.1%, to $41.8 million in the second quarter of 2018. This increase mainly consisted of an increase of $16.7 million in selling expenses and an increase of $5.6 million in general and administrative expenses.

Selling expenses in the second quarter of 2018 was $24.4 million compared to $3.6 million in the same quarter of 2017. More than half of the increase was related to the sales of placenta polypeptide products with the remainder related to the sales of plasma products and TianXinFu’s sales of its dura mater products. For placenta polypeptide products and certain hyper-immune products, because certain previous multi-layer distributor channels were disqualified due to the two-invoice regulation, the Company implemented new sales strategies including using an internal sales force and engaging third party contract service organizations to promote its placenta polypeptide products. For other plasma products, in order to solidify its competitiveness within distributor channel customers, the Company incurred additional promotion and marketing costs. TianXinFu’s selling expenses included a $2.0 million amortization expense for the intangible asset of customer relationships associated with the Company’s acquisition of TianXinFu. Excluding this intangible asset amortization expense, selling expenses accounted for 18.6% of total sales in the second quarter of 2018 compared to 4.0% in the same quarter of 2017.

General and administrative expenses in the second quarter of 2018 was $20.6 million compared to $14.3 million in the same quarter of 2017. As a percentage of total sales, general and administrative expenses were 17.1% and 16.0% in the second quarter of 2018 and the same quarter of 2017, respectively. The increase in general and administrative expenses mainly included a $2.7 million increase of share-based compensation expenses and a $1.0 million increase of Shandong Taibang’s depreciation expense and property tax for its new facility. Excluding the impact of share-based compensation expenses, non-GAAP general and administrative expenses would have been 8.1% and 6.9% of total sales in the second quarter of 2018 and the same quarter of 2017, respectively.

Research and development expenses in the second quarter of 2018 remained at $1.9 million compared to the same quarter of 2017. As a percentage of total sales, research and development expenses decreased to 1.6% in the second quarter of 2018 from 2.1% in the same quarter of 2017.

Income from operations for the second quarter of 2018 decreased by 15.3% in RMB terms, or 8.9% in USD terms, to $35.9 million from $39.4 million in the same quarter of 2017. Operating margin decreased to 29.8% in the second quarter of 2018 from 44.1% in the same quarter of 2017. Excluding TianXinFu, income from operations for the second quarter of 2018 decreased by 30.3% in RMB terms, or 25.1% in USD terms, to $29.5 million from $39.4 million in the same quarter of 2017.

Income tax expense was $6.7 million for the second quarter of 2018 compared to $6.9 million in the same quarter of 2017. The effective income tax rate was 16.4% and 16.5% for the second quarters of 2018 and 2017, respectively.

Net income attributable to the Company decreased by 14.1% in RMB terms, or 7.7% in USD terms, to $28.6 million in the second quarter of 2018 from $31.0 million in the same quarter of 2017. Net margin decreased to 23.8% in the second quarter of 2018 from 34.7% in the same quarter of 2017. Diluted net earnings per share decreased to $0.83 in the second quarter of 2018 compared to $1.09 in the same quarter of 2017. Excluding TianXinFu, net income attributable to the Company decreased by 29.7% in RMB terms, or 24.2% in USD terms, in the second quarter of 2018 compared to the same quarter of 2017, and net margin decreased to 21.9% in the second quarter of 2018 from 34.8% in the same quarter of 2017.

Non-GAAP adjusted income from operations decreased by 3.7% in RMB terms, or increased by 3.6% in USD terms, to $49.2 million in the second quarter of 2018 from $47.5 million in the same quarter of 2017. Excluding TianXinFu, non-GAAP adjusted income from operations decreased by 21.0% in RMB terms, or 15.1% in USD terms, in the second quarter of 2018 compared to the same quarter of 2017.

Non-GAAP adjusted net income attributable to the Company decreased by 2.8% in RMB terms, or increased by 4.4% in USD terms, to $40.2 million in the second quarter of 2018 from $38.5 million in the same quarter of 2017. Non-GAAP net margin decreased to 33.4% in the second quarter of 2018 from 43.1% in the same quarter of 2017. Non-GAAP adjusted net income per diluted share decreased to $1.17 in the second quarter of 2018 from $1.35 in the same quarter of 2017. Excluding TianXinFu, non-GAAP adjusted net income attributable to the Company decreased by 19.4% in RMB terms, or 13.2% in USD terms, in the second quarter of 2018 compared to the same quarter of 2017.

Non-GAAP adjusted income from operations for the second quarter of 2018 excludes $10.8 million in non-cash employee share-based compensation expenses and $2.5 million in amortization expense of intangible assets and land use rights related to the acquisition of TianXinFu.

Non-GAAP adjusted net income and diluted earnings per share for the second quarter of 2018 exclude $9.9 million in non-cash employee share-based compensation expenses and $1.7 million in amortization expense of intangible assets and land use rights related to the acquisition of TianXinFu.

First Half 2018 Financial Performance

Total sales in the first half of 2018 increased by 19.5% in RMB terms, or 28.8% in USD terms, to $232.8 million from $180.7 million in the same period of 2017. This includes a $24.4 million contribution from TianXinFu, which accounts for approximately 10.5% of total sales for the first half of 2018. Excluding TianXinFu, total sales in the first half of 2018 increased by 7.0% in RMB terms as a result of increases in the sales of placenta polypeptide products and certain immunoglobulin products, which was partly offset by decreases in the sales of human albumin and IVIG products. For plasma products, total sales in the first half of 2018 increased by 0.8% in RMB terms, or 8.7% in USD terms, to $175.3 million from $161.3 million in the same period of 2017. As a percentage of total sales, sales from human albumin products and IVIG products accounted for 30.9% and 25.7%, respectively, for the first half of 2018. Excluding the contribution from TianXinFu, human albumin and IVIG products were 34.5% and 28.7% of total sales, respectively.

Cost of sales increased by 14.4% to $71.3 million in the first half of 2018 compared to $62.3 million in the same period of 2017. As a percentage of total sales, cost of sales decreased to 30.6% from 34.5% in the same period of 2017. The decrease in cost of sales as a percentage of total sales mainly reflected the higher gross margin of TianXinFu. Excluding TianXinFu, cost of sales decreased to 32.9% of total sales, mainly due to the higher sales price of the Company’s placenta polypeptide product.

Gross profit increased by 36.4% to $161.5 million in the first half of 2018 from $118.4 million in the same period of 2017. Gross margin was 69.4% and 65.5% in the first half of 2018 and 2017, respectively.

Total operating expenses in the first half of 2018 was $86.7 million compared to $40.2 million in the same period of 2017. As a percentage of total sales, total operating expenses increased to 37.2% in the first half of 2018 from 22.2% in the same period of 2017. Excluding TianXinFu, total operating expenses increased by $36.3 million, or 90.3%, to $76.5 million in the first half of 2018. This increase mainly consisted of an increase of $29.8 million in selling expenses and an increase of $7.2 million in general and administrative expenses.

Income from operations for the first half of 2018 decreased by 11.3% in RMB terms, or 4.3% in USD terms, to $74.8 million from $78.2 million in the same period of 2017. Excluding TianXinFu, income from operations for the first half of 2018 decreased by 24.9% in RMB terms, or 19.1% in USD terms, in the first half of 2018 compared to the same period of 2017.

Income tax expense in the first half of 2018 was $13.5 million compared to $13.8 million in the same period of 2017. The effective income tax rate was 15.9% and 16.6% for the first halves of 2018 and 2017, respectively.

Net income attributable to the Company decreased by 8.5% in RMB terms, or 1.3% in USD terms, to $60.2 million in the first half of 2018 from $61.0 million in the same period of 2017. Net margin decreased to 25.9% in the first half of 2018 from 33.8% in the same period of 2017. Diluted earnings per share for the first half of 2018 decreased to $1.75 from $2.15 for the same period of 2017. Excluding TianXinFu, net income attributable to the Company decreased by 22.8% in RMB terms, or 16.8% in USD terms, in the first half of 2018 compared to the same period of 2017, and net margin decreased to 24.4% in the first half of 2018 from 33.8% in the same period of 2017.

Non-GAAP adjusted income from operations decreased by 2.4% in RMB terms, or increased by 5.2% in USD terms, to $99.3 million in the first half of 2018 from $94.4 million in the same period of 2017. Excluding TianXinFu, non-GAAP adjusted income from operations decreased by 18.3% in RMB terms, or 11.9% in USD terms in the first half of 2018 compared to the same period of 2017.

Non-GAAP adjusted net income attributable to the Company decreased by 0.4% in RMB terms, or increased by 7.5% in USD terms, to $81.6 million in the first half of 2018 from $75.9 million in the same period of 2017. Non-GAAP adjusted net income per diluted share decreased to $2.37 in the first half of 2018 from $2.67 in the same period of 2017. Excluding TianXinFu, non-GAAP adjusted net income attributable to the Company decreased by 15.8% in RMB terms, or 9.1% in USD terms, in the first half of 2018 compared to the same period of 2017.

Non-GAAP adjusted income from operations for the first half of 2018 excludes $19.8 million in non-cash employee share-based compensation expenses and $4.6 million in amortization expense of intangible assets and land use rights related to the acquisition of TianXinFu.

Non-GAAP adjusted net income and diluted earnings per share for the first half of 2018 exclude $18.2 million in non-cash employee share-based compensation expenses and $3.1 million in amortization expense of intangible assets and land use rights related to the acquisition of TianXinFu.

As of June 30, 2018, the Company had $103.3 million in cash on hand and demand deposits, $118.3 million in time deposits, and $144.6 million in financial instruments.

Net cash provided by operating activities for the first half of 2018 was $45.5 million, including an $11.6 million contribution from TianXinFu, compared to $36.9 million for the same period of 2017. Excluding TianXinFu, the $3.0 million decrease in net cash provided by operating activities was a combined result of: 1) the negative impact from a decrease in net income, an increase in accounts receivable, an increase in prepayments and deferred expenses, and decreases in accounts payable and tax payable; and 2) the positive impact from an increase of other payables and accrued liabilities, and a slowdown of increase in inventory compared to the first half of 2017.

Excluding TianXinFu, accounts receivable increased by $30.3 million during the first half of 2018 compared to $26.1 million in the same period of 2017. The accounts receivable turnover days for plasma products increased to 88 days during the first half of 2018 from 51 days in the same period of 2017, reflecting longer credit terms to hospitals as a result of the nationwide healthcare regulation changes and intensified competition in the distributor channel.

Excluding TianXinFu, inventories increased by $20.3 million in the first half of 2018. This is lower than a $22.8 million inventory increase in the same period of 2017, when Shandong Taibang stockpiled inventory to prepare for the planned temporary production suspension.

Excluding TianXinFu, other payables and accrued liabilities increased by $17.9 million in the first half of 2018 compared to a decrease of $2.9 million in the first half of 2017. The increase mainly reflected more marketing activities carried out by third party contract service organizations that the Company engaged to promote its placenta polypeptide and certain plasma products in compliance with the two-invoice policy.

Net cash used in investing activities for the first half of 2018 was $168.9 million compared to $16.6 million for the same period of 2017. Net cash used in investing activities in the first half of 2018 mainly consisted of a $529.6 million payment for the purchase of time deposits and financial instruments and a $19.1 million payment for the acquisition of property, plant, and equipment, intangible assets, and land use rights. This was partly offset by $97.7 million in cash received upon acquisition of TianXinFu and the maturity of $282.1 million in time deposits and financial instruments. In the same period of 2017, the Company paid $16.6 million for the acquisition of property, plant, and equipment and land use rights for Shandong Taibang and Guizhou Taibang.

Net cash provided by financing activities for the first half of 2018 was $0.8 million compared to $14.8 million for the same period of 2017. Net cash provided by financing activities in the first half of 2018 represented proceeds of $0.8 million from stock options exercised. Net cash provided by financing activities in the first half of 2017 mainly consisted of $14.3 million in short-term loan net proceeds.

Financial Outlook

The Company is making a downward revision to its full year 2018 forecast. The company expects non-GAAP adjusted income from operations to increase by 0% to 2% in RMB terms and non-GAAP adjusted net income to decrease by 2% to 4% in RMB terms over full year 2017 financial results. Excluding TianXinFu, full year 2018 non-GAAP adjusted income from operations is expected to decrease by 16% to 18% in RMB terms and non-GAAP adjusted net income to decrease by 19% to 21% in RMB terms over full year 2017 financial results.

The full year 2018 forecast was lowered to account for worse-than-expected results for the first half of 2018 and an ongoing challenging outlook in the second half of the year due to the following factors:

persisting regulatory headwinds, which places downward pressure on sales growth;
intensified competition in China’s plasma industry, which continues to drive costs higher and prices lower among plasma product providers in China;
investments in long-term improvements and upgrades to the marketing and sales capabilities, which places additional downward pressure on the bottom line; and
a one-time provision in connection with the new facility project in Guizhou and certain fixed assets among certain non-operating collection stations.
In the interest of increasing transparency, the Company intends to provide future financial outlook using non-GAAP adjusted income from operations and non-GAAP adjusted net income instead of sales. The Company believes that providing a financial outlook using income from operations, while excluding non-GAAP factors such as non-cash employee share-based compensation expenses and amortization expense of intangible assets and land use rights related to the acquisition of TianXinFu, provides greater clarity and understanding of the Company’s operations, especially in light of price surges for polypeptide products and certain hyper-immune products under the two-invoice policy accompanied by proportionately increased selling expenses.

This guidance does not factor in any potential foreign currency translation impact. Having previously adopted an exchange rate of approximately RMB6.76 = $1.00 based on weighted average quarterly exchange rates in 2017 in translating 2017 financial results, the Company expects that the non-GAAP adjusted income from operations and non-GAAP adjusted net income in USD terms in 2018 could be affected by the foreign currency translation impact.

This guidance excludes potential acquisitions, and necessarily assumes no significant adverse product price changes during 2018. 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 August 6, 2018, which is 7:30 pm Beijing Time on August 6, 2018, to discuss its second quarter 2018 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:

852 301 84992

China:

4001 201203

A telephone replay will be available one hour after the conclusion of the conference all through August 13, 2018. The dial-in details are:

US:

1 877 344 7529

International:

1 412 317 0088

Passcode:

10122849

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

On August 3, 2018 Trovagene, Inc. (NASDAQ: TROV), a clinical-stage oncology therapeutics company, developing targeted therapeutics for the treatment of leukemias, lymphomas and solid tumor cancers, reported company highlights and financial results for the second quarter ended June 30, 2018 (Press release, Trovagene,AUG 3, 2018, View Source [SID1234528423]). The company is issuing this press release in lieu of conducting a conference call.

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Trovagene is a clinical-stage oncology therapeutics company, developing targeted therapeutics for the treatment of solid tumor cancers and leukemias/lymphomas.

"We are continuing to advance our clinical development of PCM-075 in Acute Myeloid Leukemia (AML) and metastatic Castration-Resistant Prostate Cancer (mCRPC), achieving several key milestones during the second quarter," said Tom Adams, Executive Chairman of Trovagene. "In our AML trial, we have successfully completed treatment of 10 patients with PCM-075, 6 at the first dose level of 12 mg/m2 and 4 at the second dose level of 18 mg/m2, in combination with either low-dose cytarabine (LDAC) or decitabine. I’m also pleased to report that we received Investigational Review Board (IRB) approval for our Phase 2 trial of PCM-075 in combination with abiraterone acetate (Zytiga) in patients with mCRPC from the Harvard Medical Cancer Centers and patient recruitment is underway."

During the second quarter of 2018 the Company has advanced its business with the following activities:

Announced Preliminary Clinical Data from First Dosing Cohort Demonstrating Durable Treatment Effect of PCM-075 in Combination with Cytarabine or Decitabine in Patients with Relapsed or Refractory AML
On June 27, 2018, Trovagene announced preliminary clinical data from the first dosing cohort showing a treatment effect with PCM-075 in combination with low-dose cytarabine (LDAC) or decitabine, as measured by decreases in leukemic cells in both peripheral blood and bone marrow in patients in its ongoing Phase 1b/2 trial in relapsed or refractory Acute Myeloid Leukemia (AML). Both blood and bone marrow samples were obtained from patients with relapsed or refractory AML enrolled in the Phase 1b/2 trial prior to, and at timepoints following administration of PCM-075, in combination with cytarabine or decitabine. Among the 6 patients evaluated, no dose-limiting toxicities (DLTs) were observed that would prohibit further escalation of the PCM-075 dosing. Three patients exhibited substantial reductions in the percentage of both circulating leukemic cells within the blood and leukemic cells within the bone marrow. Two of these three patients continued on treatment in the second cycle and further decreases in circulating leukemic cells in the blood and within the bone marrow were observed. One patient had a decrease in his bone marrow blasts from 96% to 40% at the end of cycle 2 and has continued on treatment in cycle 3.
Announced the Start of Recruitment and Enrollment for Phase 2 Clinical Trial of PCM-075 in Combination with Zytiga in Patients with mCRPC
On June 21, 2018, Trovagene announced it has received Institutional Review Board (IRB) approval from Dana-Farber/Harvard Cancer Center and its Phase 2 clinical trial of PCM-075 in combination with Zytiga (abiraterone acetate) and prednisone in mCRPC is officially activated and recruiting patients. The trial is being conducted by Beth Israel Deaconess Medical Center (BIDMC), Dana-Farber Cancer Institute (Dana-Farber), and Massachusetts General Hospital Cancer Center (MGH). David Einstein, MD, Genitourinary Oncology Program at BIDMC, is the principal investigator for the trial.
Announced Completion of First Dosing Cohort of Patients Treated with PCM-075 in Combination with Decitabine in Ongoing Phase 1b/2 AML trial
On June 15, 2018, Trovagene announced completion of the first dose cohort of PCM-075 in combination with decitabine, in its Phase 1b/2 clinical trial in patients with AML. Three patients were treated with PCM-075 at 12 mg/m2, administered orally, once daily, on days 1-5 of the treatment cycle, in combination with decitabine. The combination of PCM-075 and decitabine was well tolerated in all patients. The independent Safety Review Committee (SRC) has recommended escalating to the second dose cohort of three patients at 18 mg/m2 of PCM-075 (approximately a 50% increase) in combination with decitabine.
Announced Completion of First Dosing Cohort of Patients in Ongoing Phase 1b/2 AML trial of PCM-075 in Acute Myeloid Leukemia
On May 17, 2018, Trovagene announced the completion of the first dose cohort in its Phase 1b/2 clinical trial of PCM-075 in combination with LDAC, in AML. Three patients were treated with PCM-075 at 12 mg/m2, administered orally, once daily, on days 1-5 of the treatment cycle, in combination with LDAC. Patients eligible for Phase 1b have relapsed or refractory disease and may have received as many as three prior regimens for treatment of their AML. The combination of PCM-075 and LDAC was well tolerated in all patients. The independent Safety Review Committee (SRC) has recommended escalating to the second dose cohort of three patients at PCM-075 at 18 mg/m2 (approximately a 50% increase) in combination with LDAC.
Announced Presentation of Data at AACR (Free AACR Whitepaper) Meeting 2018 on Pharmacodynamic and Tumor Biomarkers During Treatment with PCM-075 and Low-Dose Cytarabine
On April 17, 2018, Trovagene announced the presentation of pharmacodynamic and biomarker data from the first patient to complete a safety treatment cycle in its Phase 1b/2 clinical trial of PCM-075 in AML at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, IL. The poster entitled Pharmacodynamic and Tumor Biomarker Analysis of a PLK1 Inhibitor, PCM-075, in a Phase 1b/2 Trial for Acute Myeloid Leukemia presents the methodology developed to track dynamic changes in blood leukemic cells, genomic alterations and PLK1 inhibition in AML patients treated with PCM-075 in combination with LDAC.
Announced Presentation of data at AACR (Free AACR Whitepaper) Meeting 2018 Showing Synergy of PCM-075 in Combination with FLT3 Inhibitors in Acute Myeloid Leukemia (AML)
On April 16, 2018, Trovagene announced the presentation of data showing that PCM-075 exhibits synergistic activity when combined with FLT3 inhibitors in a human xenograft AML model, at the AACR (Free AACR Whitepaper) Annual Meeting in Chicago, IL. The poster entitled Selective Polo-like Kinase 1 (PLK1) Inhibitor PCM-075 is Highly Active Alone and Shows Synergy When Combined with FLT3 Inhibitors in Models of Acute Myeloid Leukemia (AML) presents data demonstrating that PCM-075 in combination with quizartinib (Daiichi-Sankyo) resulted in 97.3% tumor growth inhibition (TGI), compared to 77.9% with quizartinib and 80.2% with PCM-075 as monotherapy.
Second Quarter 2018 Financial Results

Trovagene received gross proceeds of approximately $18.0 million from the sale of 9,140,000 shares of its common stock, 20,700,000 shares of warrants, and 8,600 shares of Series B Convertible Preferred Stock through an underwritten public offering that closed on June 12, 2018.
Trovagene reported a net loss of $3.7 million and a net loss of $6.5 million attributable to common shareholders, or $0.88 per diluted share in the second quarter of 2018, as compared to a net loss of $8.0 million and a net loss of $8.1 million attributable to common shareholders, or $3.12 per diluted share for the same quarter of 2017. The Company recorded a $2.8 million one-time, non-cash deemed dividend related to the beneficial conversion feature arising from the issuance of Series B Convertible Preferred Stock. Adjusted net loss per common share (non-GAAP) was $0.44 in the second quarter of 2018, as compared to adjusted net loss per common share (non-GAAP) of $3.12 for the same quarter of 2017. There will be no need to account for any subsequent, similar one-time, non-cash deemed dividends for Series B Convertible Preferred Stock issued in the June public offering.
Total operating expenses were approximately $4.6 million for the three months ended June 30, 2018, a reduction of $1.4 million from $6.0 million for the same period in 2017. The decrease in cash used in operating activities is attributed to having completed the transition from diagnostics to therapeutics and primary focus on advancing development of PCM-075.
Net cash used in operating activities in the second quarter of 2018 was $3.3 million, compared to $4.6 million in the second quarter of 2017. The year-over-year reduction of $1.3 million can be attributed primarily to the elimination of expenses associated with diagnostic programs and focus on therapeutics and the clinical development of its lead drug candidate, PCM-075.
Net cash provided by financing activities in the second quarter of 2018 was $15.1 million as compared to $16.7 million used in financing activities in the same period of 2017. Financing activities during the three months ended June 30, 2018 related primarily to the proceeds from sales of common stock and warrants.
Research and development expenses increased by approximately $1.0 million to $2.0 million for the three months ended June 30, 2018 from $1.0 million for the same period in 2017. The overall increase in research and development expenses was primarily due to the increased outside service costs for clinical studies related to the development of our drug candidate, PCM-075. We expect increases in research and development costs as we continue to advance the development of PCM-075.
Selling, general and administrative expenses decreased by approximately $2.5 million to $2.2 million for the three months ended June 30, 2018 from $4.7 million for the same period in 2017. The significant components of the decrease were primarily due to the decrease in legal fees of approximately $2.1 million related to former CEO and CFO litigation settlement.
The weighted average diluted shares of common stock outstanding used to calculate per share results for the three months ended June 30, 2018 was 7.4 million.
As of June 30, 2018, Trovagene had approximately $18.5 million of cash and cash equivalents.

On August 3, 2018 bluebird bio, Inc. (Nasdaq: BLUE) reported that members of the management team will present at the 2018 Wedbush PacGrow Healthcare Conference, Tuesday, August 14, at 8:35 a.m. ET at the Parker New York Hotel, New York City (Press release, bluebird bio, AUG 3, 2018, View Source [SID1234528416]).

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To access the live webcast of bluebird bio’s presentation, please visit the "Events & Presentations" page within the Investors and Media section of the bluebird bio website at View Source A replay of the webcast will be available on the bluebird bio website for 90 days following the conference.

On August 3, 2018 Omeros Corporation (NASDAQ: OMER) reported that the company will issue its second quarter 2018 financial results for the period ended June 30, 2018, on Thursday, August 9, 2018, after the market closes (Press release, Omeros, AUG 3, 2018, View Source;p=RssLanding&cat=news&id=2361970 [SID1234528383]). Omeros management will host a conference call and webcast that day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results.

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!

Conference Call Details

To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 3989669. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 3989669.

To access the live and subsequently archived webcast of the conference call, go to Omeros’ website at www.omeros.com and go to "Events" under the Investors section of the website. Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.