On August 1, 2018 PRA Health Sciences, Inc. ("PRA," "we," "us" or the "Company") (NASDAQ: PRAH) reported financial results for the quarter ended June 30, 2018 (Press release, PRA Health Sciences, AUG 1, 2018, View Source [SID1234528665]).

For the three months ended June 30, 2018, revenue was $722.8 million, which represents growth of 35.4%, or $189.1 million, compared to the second quarter of 2017 at actual foreign exchange rates. On a constant currency basis, revenue grew $182.3 million, an increase of 34.2% compared to the second quarter of 2017. On January 1, 2018, the Company adopted Accounting Standards Codification Topic 606, "Revenue from Contracts with Customers," or ASC 606, using the modified retrospective method for all contracts that were not completed as of January 1, 2018. The prior periods were not restated under this guidance and remain as previously reported. The primary impact of applying this new guidance on our statement of operations is that (i) we now recognize reimbursements from our customers for payments to investigators as revenue, whereas these payments and costs were previously recorded on a net basis, and (ii) we include all reimbursed costs in the total project costs when measuring our progress under our research contracts instead of recording these amounts on a separate basis.

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Excluding the impact of the adoption of ASC 606 and reimbursement revenue, revenue increased $117.0 million, which represents growth of 25.6% at actual foreign exchange rates and 24.4% on a constant currency basis. Organic revenue growth, excluding the adoption of ASC 606, reimbursement revenue and $58.1 million of revenue attributable to our Data Solutions segment, was 12.9% at actual foreign exchange rates and 11.7% on a constant currency basis.

Net new business for our Clinical Research segment for the quarter ended June 30, 2018 was $670.0 million, representing a net book-to-bill ratio of 1.30 for the period. Our calculation of the net book-to-bill ratio excludes the revenue impact of adopting ASC 606, excludes reimbursement revenue and excludes revenue from our Data Solutions segment. Net new business during the quarter contributed to an ending backlog of $3.9 billion at June 30, 2018.

"I am pleased with our second quarter performance, which included double-digit revenue, earnings and net new business growth when compared to the second quarter of 2017" said Colin Shannon, PRA’s Chief Executive Officer. "We continue to stay focused on our client deliverables and our strategic objectives. We are pleased to continue to add new clients and believe we are well-positioned to drive future growth."

Direct costs were $381.7 million during the three months ended June 30, 2018 compared to $300.6 million for the second quarter of 2017. The increase in direct costs was primarily due to an increase in labor-related costs of $36.4 million in our Clinical Research segment as we continue to hire billable staff to ensure appropriate staffing levels for our current studies and our future growth. In addition, our Data Solutions segment resulted in $41.6 million of incremental direct costs when compared to the second quarter of 2017. We also had an unfavorable impact of $5.3 million from fluctuation in foreign currency exchange rates during the three months ended June 30, 2018. Excluding the impact of the adoption of ASC 606 and reimbursement revenue, direct costs were 66.4% of revenue during the second quarter of 2018 compared to 65.6% of revenue during the second quarter of 2017.

Selling, general and administrative expenses were $91.2 million during the three months ended June 30, 2018 compared to $76.2 million for the second quarter of 2017. Excluding the impact of the adoption of ASC 606 and reimbursement revenue, selling, general and administrative costs were 15.9% of revenue during the second quarter of 2018 compared to 16.6% of revenue during the second quarter of 2017.

GAAP net income was $42.0 million for the three months ended June 30, 2018, or $0.64 per share on a diluted basis, compared to GAAP net income of $29.5 million for the three months ended June 30, 2017, or $0.45 per share on a diluted basis.

EBITDA was $102.6 million for the three months ended June 30, 2018, representing an increase of 55.9% compared to the second quarter of 2017. Adjusted EBITDA was $109.7 million for the three months ended June 30, 2018, representing growth of 28.5% compared to the second quarter of 2017.

Adjusted net income was $66.1 million for the three months ended June 30, 2018, representing 27.8% growth compared to the second quarter of 2017. Adjusted net income per diluted share was $1.00 for the three months ended June 30, 2018, representing 26.6% growth compared to the second quarter of 2017.

A reconciliation of our non-GAAP measures, including EBITDA, adjusted EBITDA, adjusted net income, adjusted net income per diluted share and our 2018 guidance, to the corresponding GAAP measures is included in this press release.

First Half 2018 Financial Highlights

For the six months ended June 30, 2018, revenue was $1,424.7 million, which represents growth of 39.5%, or $403.2 million, compared to the six months ended June 30, 2017 at actual foreign exchange rates. On a constant currency basis, revenue grew $380.6 million, representing growth of 37.3% compared to the six months ended June 30, 2017.

Excluding the impact of the adoption of ASC 606 and reimbursement revenue, revenue increased $249.9 million, which represents growth of 28.2% at actual foreign exchange rates and 26.4% on a constant currency basis. Organic revenue growth, excluding the adoption of ASC 606, reimbursement revenue and $114.9 million of revenue attributable to our Data Solutions segment, was 15.3% at actual foreign exchange rates and 13.4% on a constant currency basis.

Reported GAAP income from operations was $145.7 million, reported GAAP net income was $81.0 million and reported GAAP net income per diluted share was $1.22 for the six months ended June 30, 2018.

Adjusted Net Income was $122.3 million for the six months ended June 30, 2018, an improvement of 32.8% compared to the same period in 2017. Adjusted Net Income per diluted share was $1.85 for the six months ended June 30, 2018, up 32.1% compared to the same period in 2017.

The Company is updating its full year 2018 revenue guidance to between $2.87 billion and $2.92 billion, representing as reported growth of 47% to 50%, constant currency growth of 18% to 20% excluding the impact of adopting 606 and reimbursement revenue, and constant currency organic growth of 10% to 12% excluding the impact of adopting 606 and reimbursement revenue. We expect GAAP net income per diluted share to between $2.92 and $3.02 and Adjusted Net Income per diluted share to between $4.13 and $4.23. We continue to anticipate an annual effective income tax rate estimate of approximately 24%, which includes the expected impact of the U.S. Tax Cuts and Jobs Act. Our effective tax rate may differ from this estimate, due to, among other things, changes to estimates of the geographic allocation of our pre-tax income as well as changes in interpretations, analysis, and additional guidance that may be issued by regulatory agencies as it relates to the U.S. Tax Cuts and Jobs Act.

Our guidance assumes a EURO rate of 1.20 and a GBP rate of 1.37. All other foreign currency exchange rates are as of June 30, 2018.

Conference Call Details

PRA will host a conference call at 9:00 a.m. ET on August 2, 2018, to discuss the contents of this release and other relevant topics. To participate, please dial (877) 930-8062 within the United States or (253) 336-7647 outside the United States approximately 10 minutes before the scheduled start of the call. The conference ID for the call is 9692658. The conference call will also be accessible, live via audio broadcast, on the Investor Relations section of the PRA website at investors.prahs.com. A replay of the conference call will be available online at investors.prahs.com. In addition, an audio replay of the call will be available for one week following the call and can be accessed by dialing (855) 859-2056 within the United States or (404) 537-3406 outside the United States. The replay ID is 9692658.

Additional Information

A financial supplement with second quarter 2018 results, which should be read in conjunction with this press release, may be found in Investor Relations section of our website at investors.prahs.com in a document titled "Q2 2018 Earnings Presentation."

On August 1, 2018 Alkermes plc (Nasdaq: ALKS) reported that its corporate presentation will be webcast live at the 38th Annual Canaccord Genuity Growth Conference on Wednesday, Aug. 8, 2018 at 10:30 a.m. ET (3:30 p.m. BST) from Boston (Press release, Alkermes, AUG 1, 2018, View Source;p=RssLanding&cat=news&id=2361402 [SID1234528866]). The presentation may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

Contact:
Sandra Coombs
Investor Relations
+1 781 609 6377

On August 1, 2018 MorphoSys AG reported its results for the second quarter of 2018(Press release, MorphoSys, AUG 1, 2018, View Source/medien-investoren/mediencenter/morphosys-ag-gibt-ergebnisse-des-zweiten-quartals-2018-bekannt" target="_blank" title="View Source/medien-investoren/mediencenter/morphosys-ag-gibt-ergebnisse-des-zweiten-quartals-2018-bekannt" rel="nofollow">View Source [SID1234528298]).

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The company has continued to expand its pipeline of proprietary and partner-developed programs and established a presence in the US to prepare for commercialization

Conference Call and Webcast on August 2, 2018 at 2:00 pm CEST

– ongoing discussions with the US Food and Drug Administration (FDA) on marketing approval of MOR208 as a potential treatment for aggressive lymphoma (DLBCL) within the existing status of the treatment breakthrough

– First clinical data from the ongoing Phase 2 trial with MOR208 plus idelalisib in CLL presented at the annual meeting of the European Hematology Association (EHA) (Free EHA Whitepaper)

– Jennifer Herron takes over leadership of the newly formed MorphoSys US Inc. and is responsible for building commercial structures for MOR208

– MorphoSys and Galapagos sign a worldwide licensing agreement with Novartis for MOR106. MorphoSys and Galapagos will jointly receive an upfront payment of € 95 million and significant potential future milestone payments and royalties in the double-digit percentage range

– Partner Janssen starts phase 2/3 program with Tremfya (R) in Crohn’s disease

– Partner Roche launches phase 3 trial with gantenerumab in patients with early Alzheimer’s disease

– US Nasdaq IPO and successful capital increase with gross proceeds of $ 239 million completed in April 2018

– Liquidity position increased to 450.5 million euros (as at 30 June 2018)

– Following the signing of a license agreement with Novartis for MOR106 and subject to US antitrust approval, MorphoSys is increasing its financial guidance for 2018 and expects sales of between EUR 67 and 72 million, EBIT of EUR -55 to -65 million and expenses for the development of proprietary programs and technology development from 87 to 97 million euros

MorphoSys AG (Prime Standard Segment, TecDAX, NASDAQ: MOR) reported its results for the second quarter of 2018.

"MorphoSys has made excellent progress in many areas during the quarter, and we have continued our constructive discussions with the FDA on a possible route to market approval for MOR208 for the treatment of aggressive lymphoma (DLBCL) and positive data from a current Phase 2 trial Study with MOR208 in chronic lymphocytic leukemia (CLL), "commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "With the formation of our new US subsidiary MorphoSys US Inc. and the appointment of Jennifer Herron as their director, we have laid the foundation for a strong sales presence to prepare for the potential future commercialization of MOR208, subject, of course, to approval for this development Drug by the FDA. "

"We are also very pleased with the progress made by our partners, notably the successful marketing of Tremfya (R) to treat psoriasis by Janssen, as well as the launch of additional pivotal development programs with Tremfya (R) in Crohn’s disease by Janssen and Gantenerumab in Alzheimer’s by Roche, "Dr. Moroney continues.

"An exciting quarter is behind us, and MorphoSys’s recent corporate developments are giving us an optimistic outlook for the future: In April, we completed our IPO on Nasdaq and signed an exclusive license agreement with Novartis for MOR106 shortly after the end of the quarter," said Jens Holstein , Chief Financial Officer of MorphoSys AG. "Our strong financial position allows us to provide the necessary resources for our most advanced MOR208 program, to continue developing our remaining pipeline programs and to expand our commercial activities in the US."

Financial Report for the second quarter of 2018 (IFRS, all figures rounded)

In the second quarter of 2018, MorphoSys continued to focus on drug discovery and development, both independently and for partners. Consolidated revenues in the second quarter of 2018 came to EUR 8.1 million (Q2 2017: EUR 11.7 million). The expected decrease compared to the second quarter of the previous year mainly results from the termination of the partnership with Novartis in 2017. As Janssen’s contractually agreed revenue share for the second quarter of 2018 has not yet been received due to the reporting periods of Janssen and MorphoSys, Based on Janssen / J & J’s publicly announced Tremfya (R) sales revenues, the second-quarter 2018 Tremfya (R) revenue was recognized in the second quarter of 2018.

Im Segment Proprietary Development konzentriert sich MorphoSys auf die Erforschung und Entwicklung eigener Produktkandidaten in den Bereichen Krebs und entzündliche Erkrankungen. In Q2 2018 verzeichnete dieses Segment Umsätze von 0,1 Mio. Euro (Q2 2017: 0,3 Mio. Euro). Im Segment Partnered Discovery setzt MorphoSys seine firmeneigene Technologie ein, um neue Antikörper für Pharmaunternehmen zu generieren. Das Unternehmen profitiert von den Entwicklungsfortschritten der Partner in Form von finanzierten Forschungsleistungen, Lizenzgebühren, erfolgsbasierten Meilensteinzahlungen und Tantiemen (Umsatzbeteiligungen). Im ersten Quartal 2018 beliefen sich die Umsätze in diesem Segment auf 8,1 Mio. Euro (Q2 2017: 11,5 Mio. Euro).

Die gesamten betrieblichen Aufwendungen erreichten im zweiten Quartal 2018 eine Höhe von 32,7 Mio. Euro (Q2 2017: 27,5 Mio. Euro). Die Aufwendungen für die Entwicklung eigener Produkte und Technologieentwicklung beliefen sich auf 23,7 Mio. Euro (Q2 2017: 18,6 Mio. Euro). Die Zunahme im Vergleich zum Vorjahr ist vor allem auf die Kosten für die Weiterentwicklung von MOR208 zurückzuführen.

Earnings before interest and taxes (EBIT) amounted to € -24.1 million in the second quarter of 2018 (Q2 2017: € -15.4 million). The Proprietary Development segment generated EBIT of
€ -24.6 million (Q2 2017: € -18.3 million). EBIT in the Partnered Discovery segment amounted to € 5.5 million (Q2 2017: € 6.8 million).
Consolidated net income amounted to EUR -23.5 million in the second quarter of 2018 (Q2 2017: EUR -16.1 million). Earnings per share reached -0.76 euros (Q2 2017: -0.56 euros).

At the end of the second quarter of 2018, MorphoSys had cash and cash equivalents of € 450.5 million, compared to € 312.2 million at December 31, 2017. This cash and cash equivalents are shown in the balance sheet in the following items: cash and cash equivalents ; financial assets at fair value, with changes recognized in profit or loss, and other current and non-current financial assets at amortized cost. The increase in cash and cash equivalents resulted primarily from the capital increase in the context of the successful Nasdaq IPO in April 2018 with gross proceeds of $ 239 million. Part of the cash and cash equivalents were used for operating expenses in the second quarter of 2018.

The total number of shares outstanding was 31,808,035 at the end of the second quarter of 2018 (31 December 2017: 29,420,758). The main reason for the increase in the number of shares was the capital increase in connection with the listing on the Nasdaq in April 2018.

Result for the first half of 2018

In the first six months of 2018, Group sales amounted to € 10.9 million (Q1-Q2 2017: € 23.6 million). Expenses for the development of own products and technology development amounted to 39.2 million Euro in the first six months of 2018 (Q1-Q2 2017: 37.3 million Euro). EBIT in the first six months of 2018 was thus EUR -43.2 million, compared with EUR -30.3 million in the first half of 2017.

Financial forecast and operational outlook for 2018

Following the recent signing of an agreement with Novartis for MOR106 and subject to the approval of the US antitrust authorities, MorphoSys is raising its financial guidance for 2018. Subject to approval by the US antitrust authorities, MorphoSys expects revenues of € 67 million to € 72 million and Earnings before interest and taxes (EBIT) of € -55 million to € -65 million. R & D expenses for proprietary programs and technology development are expected in a range of € 87 million to € 97 million. This forecast does not include additional revenues from potential future collaborations and / or licensing partnerships nor effects from possible in-licensing or development partnerships for new drug candidates.

In the Proprietary Development segment, MorphoSys expects the following events and activities for the current year:

MOR208

– L-MIND: Continued analysis of all 81 patients with relapsed / refractory diffuse large B-cell lymphoma (R / R DLBCL) enrolled in the study and presented updated clinical data at an appropriate medical conference.

– B-MIND: Continuation of the pivotal phase 3 trial with MOR208 plus bendamustine versus rituximab plus bendamustine in R / R DLBCL.

– COSMOS: continuation of Phase 2 trial with MOR208 in combination with idelalisib or Venetoclax in CLL / SLL and presentation of results from cohort B of the study (MOR208 plus Venetoclax) at an appropriate scientific conference.

– Commercial activities: Further build commercial structures for MOR208 in the US, under the umbrella of the newly formed MorphoSys US Inc., in anticipation of a potential launch, which is currently expected in 2020, subject to regulatory approval from the US Food and Drug Administration.

MOR202

– Multiple Myeloma (MM): MorphoSys has decided not to continue the development of MOR202 in MM beyond the completion of the ongoing Phase 1 / 2a trial; the final data is expected to be presented at one of the next medical conferences. MorphoSys will support its partner I-Mab as planned in the development of MOR202 for the Chinese market.

– Lung cancer (NSCLC): After Janssen discontinued a clinical trial with the CD38 antibody daratumumab in combination with a checkpoint inhibitor, MorphoSys has decided not to continue its activities in NSCLC for the time being.

– Other indications: MorphoSys continues to investigate the development of MOR202 in other indications.

MOR106: Continuing ongoing development with Galapagos as part of the new global licensing partnership with Novartis:

– Continuation of ongoing Phase 2 trial IGUANA in atopic dermatitis.

– Start of a Phase 1 study to investigate a subcutaneous formulation of MOR106.

– All future costs associated with the development of MOR106 will be borne by Novartis.

– Agreement between MorphoSys, Galapagos and Novartis is subject to approval by the US antitrust authorities.

MOR107: Continuation of pre-clinical studies of MOR107 with a focus on cancer indications to prepare a decision to conduct further clinical trials.

MOR103 / GSK3196165: Following the recent announcement by GSK that positive Phase 2b study results for GSK3196165 in rheumatoid arthritis will be presented at a future scientific conference and that the indication for osteoarthritis has been terminated, clinical data are expected to be published by GSK.

In the Partnered Discovery segment, MorphoSys 2018 expects the following events:

Tremfya (R) (Guselkumab): For several phase 3 studies in psoriasis, clinicaltrials.gov expects primary completion date in 2018, including a comparative study with Tremfya (R) and Cosentyx (R) (Secukinumab) in plaque psoriasis.

Other Affiliate Programs: Clinical data and possible regulatory milestones could be released throughout the year for many other affiliate programs.

MorphoSys will continue to expand its own development activities and review potential in-licensing, co-development and / or acquisition opportunities. In addition, the company plans to initiate further development programs of its own with the aim of maintaining and expanding the company’s position in its current therapeutic and technological fields of activity.

Percentage points ** Including MOR107, for which a Phase 1 trial with healthy volunteers was completed. MOR107 is currently undergoing preclinical research focusing on oncology. Due to ongoing studies in various indications, we continue to consider Tremfya (R) as a Phase 3 program

*** Includes MOR103 / GSK3196165, which is fully out-licensed to GSK.

MorphoSys will host a webcast public conference call on August 2, 2018, to present the financial results for the second quarter of 2018 and the outlook for 2018.

Dial-in dates for the analyst conference call (2:00 pm CEST) (Listening mode):
Germany +49 (0) 69 201 744 210
+49 (0) 89 204 049 750

Participant PIN 63419794 #

Please dial in ten minutes before the start of the conference. A live webcast and the presentation will also be available at View Source . About two hours after the end of the conference, you will be able to access an audio replay synchronized with the presentation and the transcript of the conference at View Source .

On August 1, 2018 Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX), ("Foamix"), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, reported that it will report financial results for the three and six-month periods ended June 30, 2018, on Wednesday, August 8 after the markets close (Press release, Foamix, AUG 1, 2018, View Source [SID1234528363]).

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Due to the proximity of the Company receiving data from the confirmatory Phase 3 study of FMX101 in acne, the Company will not be hosting an earnings conference call. As previously disclosed, the Company expects to announce top line results from this Phase 3 study in acne during this current quarter and will address investor questions, including those regarding financial results, at that time

On August 1, 2018 Blueprint Medicines Corporation (NASDAQ: BPMC), a leader in discovering and developing targeted kinase medicines for patients with genomically defined diseases, reported financial results and provided a business update for the second quarter ended June 30, 2018 (Press release, Blueprint Medicines, AUG 1, 2018, View Source [SID1234528283]).

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"In the second quarter, Blueprint Medicines continued to advance a broad portfolio, with progress across multiple programs," said Jeff Albers, Chief Executive Officer of Blueprint Medicines. "Importantly, we reported updated data from our Phase 1 EXPLORER trial in patients with advanced systemic mastocytosis that showed profound and durable clinical activity in nearly all patients. These data, combined with previously reported data from our ongoing Phase 1 NAVIGATOR trial in advanced gastrointestinal stromal tumors, reinforce our confidence in avapritinib as a potentially transformative therapy across multiple patient populations. By the end of this year, we expect to have four pivotal clinical trials of avapritinib underway, with the potential to rapidly advance toward approval in defined patient populations."

Clinical Programs:

Avapritinib: Gastrointestinal Stromal Tumors (GIST)

In June 2018, Blueprint Medicines announced the dosing of the first patient in its Phase 3 VOYAGER clinical trial, which will evaluate the safety and efficacy of avapritinib compared to regorafenib in patients with third- or fourth-line advanced GIST.
In June 2018, Blueprint Medicines presented data from a retrospective natural history study of patients with advanced PDGFRα D842V-driven GIST at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The data confirmed that patients with advanced PDGFRα D842V-driven GIST are unlikely to respond to currently available tyrosine kinase inhibitors (TKIs), illustrating the high unmet need for new therapies in this patient population with a short survival rate.
Blueprint Medicines continues to evaluate avapritinib in its Phase 1 NAVIGATOR clinical trial and anticipates presenting updated data across multiple patient populations, including PDGFRA-driven GIST, third-line or later GIST and second-line GIST, in the second half of 2018. Additionally, based on data from this trial, the Company plans to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for avapritinib for the treatment of patients with PDGFRA-driven GIST and fourth-line KIT-driven GIST in the first half of 2019.
Avapritinib: Advanced Systemic Mastocytosis (SM)

In June 2018, Blueprint Medicines presented updated clinical data from its ongoing Phase 1 EXPLORER clinical trial of avapritinib in patients with advanced SM at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper). The data showed an overall response rate of 83 percent and durable ongoing responses up to 22 months. All evaluable patients showed marked decreases on one or more objective measures of mast cell burden, regardless of advanced SM subtype, previous treatment or starting dose level. The data also showed that avapritinib was generally well-tolerated. Most adverse events reported by investigators were Grade 1 or 2, and only three patients discontinued due to a treatment-related adverse event. Read the full data here.
Blueprint Medicines plans to initiate screening of patients for enrollment in PATHFINDER, a registration-enabling, open-label, single-arm Phase 2 clinical trial in patients with advanced SM, in the third quarter of 2018, and plans to initiate PIONEER, a registration-enabling, randomized, placebo-controlled Phase 2 clinical trial in patients with indolent and smoldering SM, by the end of 2018.
BLU-667: RET-Altered Solid Tumors

Blueprint Medicines continues to enroll patients in the expansion portion of its ongoing Phase 1 ARROW clinical trial of BLU-667 at a dose of 400 mg once daily. In the expansion, patients are being enrolled in four defined cohorts: RET-altered non-small cell lung cancer (NSCLC) patients previously treated with a TKI; RET-altered NSCLC patients who have not previously received any TKI treatment; patients with medullary thyroid cancer; and patients with other RET-altered solid tumors.
BLU-554: Hepatocellular Carcinoma (HCC)

In June 2018, Blueprint Medicines announced plans to initiate a proof-of-concept clinical trial with CStone Pharmaceuticals in China to evaluate BLU-554 in combination with CS1001, a clinical-stage anti-programmed death ligand-1 (PD-L1) immunotherapy being developed by CStone Pharmaceuticals, as a first-line treatment for patients with HCC. Additionally, the companies plan to expand Blueprint Medicines’ ongoing Phase 1 clinical trial of BLU-554 as a monotherapy to include new sites in Mainland China. The companies expect to submit an investigational new drug (IND) application for BLU-554 to the Chinese health authorities by the end of 2018, and plan to initiate the clinical trial evaluating BLU-554 in combination with CS1001 and the expansion of Blueprint Medicines’ ongoing clinical trial for BLU-554 as a monotherapy in Mainland China in 2019.
Corporate:

In June 2018, Blueprint Medicines announced an exclusive collaboration and license agreement with CStone Pharmaceuticals to develop and commercialize avapritinib, BLU-554 and BLU-667 in Mainland China, Hong Kong, Macau and Taiwan, either as a monotherapy or as part of a combination therapy. Under the terms of the agreement, Blueprint Medicines received an upfront cash payment of $40.0 million, will be eligible to receive up to approximately $346.0 million in potential milestone payments and tiered percentage royalties in the mid-teens to low twenties on annual net sales of each licensed product in the territory.
Blueprint Medicines recently received a $10.0 million milestone payment from Roche following the achievement of a research milestone.
Second Quarter Financial Results:

Cash Position: As of June 30, 2018, cash, cash equivalents and investments were $616.7 million, as compared to $673.4 million as of December 31, 2017. This decrease was primarily related to cash used in operating activities, partially offset by the $40.0 million upfront payment received in connection with Blueprint Medicines entering into the collaboration with CStone Pharmaceuticals and the $10.0 million milestone payment received from Roche.
Collaboration Revenues: Collaboration revenues were $41.4 million for the second quarter of 2018, as compared to $5.9 million for the second quarter of 2017. This increase was primarily due to revenue recognized under the collaboration agreement with CStone Pharmaceuticals.
R&D Expenses: Research and development expenses were $58.6 million for the second quarter of 2018, as compared to $33.3 million for the second quarter of 2017. This increase was primarily attributable to increased clinical and manufacturing expenses associated with advancing avapritinib, BLU-554 and BLU-667 further through clinical trials and increased personnel-related expenses. Research and development expenses included $4.3 million in stock-based compensation expenses for the second quarter of 2018.
G&A Expenses: General and administrative expenses were $12.3 million for the second quarter of 2018, as compared to $6.8 million for the second quarter of 2017. This increase was primarily attributable to increased personnel-related expenses and increased professional fees, including pre-commercial planning activities. General and administrative expenses included $3.5 million in stock-based compensation expenses for the second quarter of 2018.
Net Loss: Net loss was $27.0 million the second quarter of 2018, or a net loss per share of $0.62, as compared to a net loss of $33.4 million for the second quarter of 2017, or a net loss per share of $0.86.
Financial Guidance:

Based on its current plans, Blueprint Medicines expects that its existing cash, cash equivalents and investments, excluding any potential option fees and milestone payments under its existing collaborations with Roche and CStone Pharmaceuticals, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the second half of 2020.

Conference Call Information:

Blueprint Medicines will host a live conference call and webcast today at 8:30 a.m. ET. The conference call may be accessed by dialing (855) 728-4793 (domestic) or (503) 343-6666 (international) and referring to conference ID 5597837. A webcast of the conference call will be available in the Investors section of Blueprint Medicines’ website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.