Aclaris Therapeutics to Announce Second Quarter 2018 Financial Results on August 3, 2018

On July 26, 2018 Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology and immunology, reported that it will report financial results for second quarter 2018 on Friday, August 3, 2018 before U.S. financial markets open (Press release, Aclaris Therapeutics, JUL 26, 2018, View Source [SID1234527876]).

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Management will conduct a conference call at 8:00 AM ET that day to discuss the Company’s financial results and provide a general business update. A live webcast of the event can be accessed on the Events and Presentations page on the Investors section of the Aclaris website at View Source A replay of the webcast will be archived on the Aclaris website following the event.

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.

Champions Oncology Reports Record Annual Revenue Exceeding $20M for Fiscal Year Ended April 30, 2018

On July 26, 2018 Champions Oncology, Inc. (Nasdaq: CSBR), engaged in the development of advanced technology solutions and services to personalize the development and use of oncology drugs, reported its financial results for the fourth fiscal quarter and 12 months ended April 30, 2018 (Press release, Champions Oncology, JUL 26, 2018, View Source [SID1234527898]).

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Fiscal Year 2018 Financial and Recent Business Highlights:

Record annual revenue of $20.2 million, an increase of 31.3% year-over-year

Record Translational Oncology Services ("TOS") revenue of $18.8 million, an increase of 37.2% year-over-year

Record annual TOS bookings

Successfully transitioned to our own new lab facility, doubling capacity, expanding revenue opportunities and realizing material cost savings

Forecast of at least 20% revenue growth in fiscal 2019 and sustained, quarterly operational profitability

Ronnie Morris, CEO of Champions, commented, "Exceeding $20 million in revenue is a significant milestone for our company, and our increasingly robust bookings and a growing pipeline of identified opportunities reinforce our optimism for the coming quarters and for revenue growth that will again exceed 20% this fiscal year. There is tremendous energy within our team about the opportunities in the market and the level of engagement from both new and existing customers."

"In addition, we made meaningful progress towards achieving our goal of sustained, long-term profitability by growing our business organically and leveraging the scale of our operations," added Mr. Morris. "Our core business is built on a highly leverageable, scalable business model that enabled us to grow our revenue by more than 30% in fiscal 2018, well ahead of our targeted 20% growth, and manage costs and operating expense to a modest increase of 4.2%. We anticipate delivering operational profitability during each quarter of fiscal 2019."

Fourth Fiscal Quarter Financial Results

Exhibit 99.1

For the fourth quarter of fiscal 2018, revenue increased 32.3% to $4.9 million compared to $3.7 million for the fourth quarter of fiscal 2017. Total operating expenses for the fourth quarter of fiscal 2018 were $5.5 million compared to $6.1 million for the fourth quarter of fiscal 2017, a decrease of $593,000 or (9.7%). For the fourth quarter of fiscal 2018, Champions reported a loss from operations of $594,000, which includes $172,000 in stock-based compensation and $110,000 in depreciation, an improvement of $1.8 million or (75.1%), compared to the loss from operations of $2.4 million, inclusive of $761,000 in stock-based compensation and $35,000 depreciation expense, in the fourth quarter of fiscal 2017. Excluding stock based compensation and depreciation, Champions reported a loss from operations for the quarter of $312,000; however, as forecasted for the full year, Champions reported income from operations of $40,000 and is positioned for sustained quarterly operational profitability going forward.

Cost of oncology solutions was $2.8 million for the three months ended April 30, 2018, an increase of $248,000, or 9.6% compared to $2.6 million for the three months ended April 30, 2017. The increase in cost of sales was due to an increase in TOS studies. For the three months ended April 30, 2018, gross margin was 42.7% compared to 30.9% for the three months ended April 30, 2017. Gross margin varies based on timing differences between expense and revenue recognition; however, the improvement can be attributed to leveraging cost of sales against a growing revenue base.

Research and development expense was $1.1 million for both the three months ended April 30, 2018 and 2017. Sales and marketing expense for the three months ended April 30, 2018 was $715,000, a decrease of $177,000, or (19.8%) compared to $892,000 for the three months ended April 30, 2017. The decrease is mainly due to a reduction of payroll and travel expenses. General and administrative expense was $888,000 for the three months ended April 30, 2018 compared to $1.6 million for the three months ended April 30, 2017, a decrease of $682,000 or (43.4%). The decrease is mainly due to a reduction in stock-based compensation expense.

Year-to-Date Financial Results

For the twelve months of fiscal 2018, revenue increased 31.3% to $20.2 million, as compared to $15.4 million for the twelve months of fiscal 2017. For the twelve months of fiscal 2018, total operating expenses decreased (2.8%) to $21.6 million, as compared to $22.2 million for the twelve months of fiscal 2017. The decrease is mainly due to a decrease in stock-based compensation.

For the twelve months ended April 30, 2018, Champions reported a loss from operations of $1.4 million, which includes $1.0 million in stock-based compensation and $360,000 in depreciation, an improvement of $5.5 million or (80.1%), compared to the loss from operations of $6.8 million, inclusive of $2.7 million in stock-based compensation and $141,000 depreciation, for the twelve months ended April 30, 2017. Excluding stock-based compensation and depreciation, Champions reported operating income of $40,000 for the twelve months ended April 30, 2018.

Net cash used in operations was $1.2 million and $2.8 million for the twelve months ended April 30, 2018 and 2017, respectively, a decrease of $1.6 million or (56.9%). The reduction in cash burn is the result of our revenue growth and expense management.

Cost of oncology solutions was $10.6 million for the twelve months ended April 30, 2018 compared to $9.7 million for the twelve months ended April 30, 2017, an increase of $850,000 or 8.8%. The increase in cost of sales was due to an increase in TOS studies. Gross margin was 47.9% for the twelve months ended April 30, 2018 compared to 37.0% for the twelve months ended April 30, 2017.The increase in cost of sales was due to an increase in TOS studies. The improvement in gross

Exhibit 99.1

margin was due to higher TOS revenue leveraged off the fixed cost component of the lab and effective management of the variable lab costs. Gross margin varies based on timing differences between expense and revenue recognition. While the gross margin improved, there are expenses incurred and recognized in advance of future revenue.

Research and development expense was $4.4 million for the twelve months ended April 30, 2018 an increase of $108,000, or 2.5% compared to $4.3 million for the twelve months ended April 30, 2017. Sales and marketing expense for the twelve months ended April 30, 2018 was $2.6 million, a decrease of $691,000, or (21.2%) compared to $3.3 million for the twelve months ended April 2017. The decrease is mainly due to reduction in salary and travel expenses. General and administrative expense was $4.1 million for the twelve months ended April 30, 2018, a decrease of 892,000 or (18.0%) compared to $5.0 million for the twelve months ended April 30, 2017. The decrease is primarily due to a reduction in stock-based compensation expense.

Conference Call Information:

The Company will host a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its fourth quarter financial results. To participate in the call, please call 877-407-8035 (domestic) or 201-689-8035 (international) ten minutes ahead of the call and give the verbal reference "Champions Oncology."

Full details of the Company’s financial results will be available Monday July 30, 2018 in the Company’s Form 10-K at www.championsoncology.com.

* Non-GAAP Financial Information

See the attached Reconciliation of GAAP net loss to non-GAAP net loss for an explanation of the amounts excluded to arrive at non-GAAP net loss and related non-GAAP net loss per share amounts for the three and twelve months ended April 30, 2018 and 2017. Non-GAAP financial measures provide investors and management with supplemental measures of operating performance and trends that facilitate comparisons between periods before and after certain items that would not otherwise be apparent on a GAAP basis. Certain unusual or non-recurring items that management does not believe affect the Company’s basic operations do not meet the GAAP definition of unusual or non-recurring items. Non-GAAP net loss and non-GAAP loss per share are not, and should not be viewed as a substitute for similar GAAP items. Champions’ defines non-GAAP dilutive loss per share amounts as non-GAAP net loss divided by the weighted average number of diluted shares outstanding. Champions’ definition of non-GAAP net loss and non-GAAP diluted loss per share may differ from similarly named measures used by others.

Asterias Biotherapeutics to Report Second Quarter 2018 Results on August 9, 2018

On July 26, 2018 Asterias Biotherapeutics, Inc. (NYSE American:AST), a biotechnology company dedicated to developing cell-based therapeutics to treat neurological conditions associated with demyelination and cellular immunotherapies to treat cancer, reported that it will release second quarter 2018 financial and operating results on Thursday, August 9, 2018 after the close of the U.S. financial markets (Press release, Asterias Biotherapeutics, JUL 26, 2018, View Source;date=July+26%2C+2018&title=Asterias+Biotherapeutics+to+Report+Second+Quarter+2018+Results+on+August+9%2C+2018 [SID1234527916]). The Company will host a conference call and webcast on August 9, 2018 at 5:00 p.m. ET / 2:00 p.m. PT to discuss the results and corporate developments.

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For both "listen-only" participants and those participants who wish to take part in the question-and-answer portion of the call, the dial-in number in the U.S./Canada is 888-599-8686. For international participants outside the U.S./Canada, the dial-in number is 323-994-2093. For all callers, refer to Conference ID 7991938. To access the live webcast, go to View Source

A replay of the conference call will be available for one month beginning about two hours after the conclusion of the live call, by calling toll-free (from U.S./Canada) 888-203-1112; international callers dial 719-457-0820. Use the Conference ID 7991938. Additionally, the archived webcast will be available at View Source

10-Q – Quarterly report [Sections 13 or 15(d)]

Amgen has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Amgen, 2018, JUL 26, 2018, View Source [SID1234527924]).

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Alkermes Plc Reports Second Quarter 2018 Financial Results

On July 26, 2018 Alkermes plc (Nasdaq: ALKS) reported financial results for the second quarter of 2018 (Press release, Alkermes, JUL 26, 2018, View Source;p=RssLanding&cat=news&id=2360206 [SID1234527877]).

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"Our strong second quarter results were driven by the solid growth of our proprietary commercial products, the continued strength of our royalty and manufacturing business, as well as the receipt of a $50 million payment related to our collaboration with Biogen for BIIB098," commented James Frates, Chief Financial Officer of Alkermes. "The business is performing as planned and today we are reiterating our financial expectations for 2018. As we head into a catalyst-rich second half of the year, we are well-positioned financially to drive value, grow our portfolio of commercial products and advance our late-stage pipeline."

Quarter Ended June 30, 2018 Financial Highlights

Total revenues for the quarter were $304.6 million. This compared to $218.8 million for the same period in the prior year, representing an increase of 39%. Proprietary product net sales for VIVITROL and ARISTADA were $109.8 million for the quarter, reflecting a 24% increase compared to the same period in the prior year.
Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $32.6 million for the quarter, or a basic and diluted GAAP net loss per share of $0.21. This compared to GAAP net loss of $43.0 million, or a basic and diluted GAAP net loss per share of $0.28, for the same period in the prior year.
Non-GAAP net income was $45.6 million for the quarter, or non-GAAP basic and diluted earnings per share of $0.29. This compared to non-GAAP net income of $1.2 million, or non-GAAP basic and diluted earnings per share of $0.01, for the same period in the prior year.
"VIVITROL and ARISTADA continue to demonstrate solid growth and perform in-line with our expectations. Our proprietary commercial portfolio is a key growth driver for Alkermes, and we are confident about the prospects ahead for these important products," stated Jim Robinson, President and Chief Operating Officer of Alkermes. "In particular, the launch of ARISTADA INITIO is an important opportunity to support continuity of care and address a critical unmet need for patients, as ARISTADA is now the first and only long-acting atypical antipsychotic that can be fully dosed on day one for up to two months. ARISTADA INITIO represents a key addition to the treatment paradigm for schizophrenia and provides a platform to further expand utilization of ARISTADA."

Quarter Ended June 30, 2018 Financial Results

Revenues

Net sales of VIVITROL were $76.2 million, compared to $66.1 million for the same period in the prior year, representing an increase of approximately 15%.
Net sales of ARISTADA were $33.6 million, compared to $22.7 million for the same period in the prior year, representing an increase of approximately 48%.
Manufacturing and royalty revenues from RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA were $85.2 million, compared to $82.2 million for the same period in the prior year.
Manufacturing and royalty revenues from AMPYRA/FAMPYRA1 were $19.7 million, compared to $25.3 million for the same period in the prior year.
License revenues from the collaboration with Biogen for BIIB098 (formerly ALKS 8700) were $48.3 million.
Research and development revenues were $18.3 million, of which $17.2 million related to the collaboration with Biogen for BIIB098.
Costs and Expenses

Operating expenses were $304.7 million, compared to $263.4 million for the same period in the prior year, primarily reflecting increased investment in the commercialization of VIVITROL and ARISTADA.
Other expense during the quarter included a $19.6 million charge due to a decrease in the fair value of contingent consideration, related to Recro Pharma, Inc.’s receipt of a complete response letter from the United States (U.S.) Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for IV Meloxicam.
"With a growing proprietary commercial portfolio and partnered royalty and manufacturing business approaching $1 billion in revenue in 2018, Alkermes is in a strong position to create significant long-term value. As we head into the second half of 2018, we are on the threshold of important value inflections across our development portfolio," said Richard Pops, Chief Executive Officer of Alkermes. "For ALKS 5461 for major depressive disorder, the regulatory review is underway and we are preparing for an Advisory Committee meeting in the fourth quarter. For ALKS 3831 for schizophrenia, enrollment of the ENLIGHTEN-2 pivotal study is complete and we expect topline data in the fourth quarter of 2018. In addition, we are on track to submit the NDA for BIIB098 toward year-end, and we look forward to presenting initial data from the ALKS 4230 phase 1 study and expanding into combination therapy later this year."

Recent Events:

ARISTADA INITIO: Following recent FDA approval, ARISTADA INITIO is now commercially available. The ARISTADA INITIO regimen2 provides physicians with an opportunity to initiate patients onto any dose of ARISTADA on day one.
ALKS 5461: Data on the long-term safety, tolerability and durability of antidepressant effect of ALKS 5461 were presented at the American Psychiatric Association (APA) and American Society of Clinical Psychopharmacology (ASCP) annual meetings.
ALKS 3831: The company presented data from the ALKS 3831 preclinical program and phase 1 translational medicine study evaluating the metabolic profile of ALKS 3831 compared to olanzapine.
BIIB098: Alkermes received a $50 million payment from Biogen in June 2018. This payment follows Biogen’s review of preliminary gastrointestinal tolerability data from the ongoing clinical development program for BIIB098.
Financial Expectations for 2018
Alkermes reiterates its financial expectations for 2018 set forth in its press release dated April 26, 2018.

Conference Call
Alkermes will host a conference call and webcast presentation with accompanying slides at 8:30 a.m. ET (1:30 p.m. BST) on Thursday, July 26, 2018, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 888 424 8151 for U.S. callers and +1 847 585 4422 for international callers. The conference call ID number is 6037988. In addition, a replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Thursday, July 26, 2018, through 5:00 p.m. ET (10:00 p.m. BST) on Thursday, Aug. 2, 2018, and may be accessed by visiting Alkermes’ website or by dialing +1 888 843 7419 for U.S. callers and +1 630 652 3042 for international callers. The replay access code is 6037988.