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Genocea Reports Third Quarter 2017 Financial Results

On November 2, 2017 Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing neoantigen cancer vaccines, reported financial results for the third quarter of 2017 and announced upcoming data presentations at a leading immuno-oncology conference (Press release, Genocea Biosciences, NOV 2, 2017, View Source [SID1234521478]).

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“We believe our proprietary ATLASTM technology sets us apart among developers of neoantigen cancer vaccines, as it offers a potential solution to one of the most significant challenges in the field – namely, identifying true neoantigens for those vaccines from up to thousands of potential candidates,” said Chip Clark, president and chief executive officer of Genocea. “ATLAS uses a patient’s own T cells to identify, rather than predict, which of the many personal mutations found in cancerous tumors are true neoantigens, which we believe will enable us to develop more immunogenic and efficacious cancer vaccines. Our upcoming data presentations at the SITC (Free SITC Whitepaper) Annual Meeting continue to support the potential of ATLAS in neoantigen identification for personalized vaccines, including our lead program, GEN-009, for which we expect to file an IND application early next year.”

GEN-009 Progress
GEN-009 is a personalized vaccine consisting of adjuvanted synthetic long peptides of true neoantigens identified by ATLAS.

The company expects to file an Investigational New Drug (IND) application in early 2018.
Genocea plans to initiate a Phase 1 clinical trial in patients with a range of tumor types in the first half of 2018, and expects to report initial immunogenicity data in the first half of 2019.
Upcoming Scientific Presentations
Genocea announced today that it will present three posters at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting taking place November 8 to 12, 2017 at the Gaylord National Hotel & Convention Center in National Harbor, Maryland.

Poster #430 entitled “Neoantigen identification using ATLAS across multiple tumor types highlights limitations of prediction algorithms,” will be presented during the session on Personalized Vaccines and Technologies/Personalized Medicine on Saturday, November 11, 2017,
Poster #8 entitled “T cell response profiling in colorectal carcinoma patients reveals an enrichment in responses to specific tumor-associated antigens,” and
Poster #28 entitled “Profiling of T cell responses to tumor-associated antigens in lung cancer patients treated with checkpoint inhibitors,” will both be presented during the session on Biomarkers and Immune Monitoring on Saturday, November 11, 2017.
Corporate Update
Following its announced restructuring at the end of the third quarter, Genocea continues to explore, alongside its advisors, strategic alternatives for GEN-003, the company’s Phase 3-ready investigational immunotherapy to treat the large patient population infected with genital herpes, many of whom are dissatisfied with their current treatment options.

Financial Guidance
Genocea expects that its existing cash and cash equivalents are sufficient to support its operating expenses and capital expenditure requirements into the middle of 2018.

Third-Quarter 2017 Financial Results

Cash Position: Cash and cash equivalents as of September 30, 2017 were $22.0 million compared to $35.2 million as of June 30, 2017.
Restructuring: A corporate restructuring was implemented following the Company’s strategic shift to immuno-oncology, resulting in a charge of approximately $1.1 million for employee severance, benefits, and related costs. These amounts will be paid in the fourth quarter of 2017. In addition, Genocea incurred approximately $0.5 million of expense due to contract termination clauses that the Company anticipates will result in future cash payments and approximately $1.0 million in non-cash asset impairment charges.
Research and Development (R&D) Expenses: R&D expenses for the quarter ended September 30, 2017 increased $1.3 million, to $10.2 million from the same period in 2016. The increase was primarily driven by higher external manufacturing-related expenses and increases in compensation to support both the clinical drug supply and clinical trial planning activities in support of the previously planned GEN-003 Phase 3 program, partially offset by reduced clinical costs, due to timing of activities in support of clinical trials. Spending increases on Genocea’s immuno-oncology and cancer vaccine programs were driven primarily by increased manufacturing and compensation, consulting and professional services in anticipation of Genocea’s expected filing of an IND application for GEN-009 in the first quarter of 2018. Increased spending on these programs was offset by lower costs on infectious disease programs previously discontinued in 2016.
General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2017 were $3.8 million, compared to $3.6 million for the same period in 2016, reflecting marginal increases in consulting and professional services offset by reductions in depreciation expense, with all other expenditures across various activities remaining consistent with the same quarter in the prior year.
Net Loss: Net loss was $16.9 million for the quarter ended September 30, 2017, compared to a net loss of $12.8 million for the same period in 2016.
Conference Call
Genocea will host a conference call and webcast today at 9:00 a.m. ET. The conference call may be accessed by dialing (844) 826-0619 for domestic participants and (315) 625-6883 for international callers and referencing the conference ID number 95267931. A live webcast of the conference call will be available online from the investor relations section of the Company’s website at View Source A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event, and will be archived for 30 days.

Evotec AG to report first nine-month 2017 results on 08 November 2017

On November 2, 2017 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) reported that it will report its financial results for the first nine months of 2017 on Wednesday, 08 November 2017 (Press release, Evotec, NOV 2, 2017, View Source [SID1234521477]).

The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

Conference call details
Date: Wednesday, 08 November 2017
Time: 02.00 pm CET (01.00 pm GMT/08.00 am EST)

From Germany: +49 69 22 22 29 043
From France: +33 170 750 705
From Italy: +39 02 3601 3806
From UK: +44 20 3009 2452
From USA: +1 855 402 7766
Access Code: 37969784#

A simultaneous slide presentation for participants dialling in via phone is available at http://www.audio-webcast.com/, password: evotec1117.

Webcast details
To join the audio webcast and to access the presentation slides you will find a link on our home page www.evotec.com shortly before the event.
A replay of the conference call will be available for 24 hours and can be accessed in Europe by dialling +49 69 22 22 33 985 (Germany) or +44 20 3426 2807 (UK) and in the USA by dialling +1 866 535 8030. The access code is 654573#. The on-demand version of the webcast will be available on our website: View Source

Asterias Biotherapeutics to Report Third Quarter Results on November 14, 2017

On November 2, 2017 Asterias Biotherapeutics, Inc. (NYSE MKT:AST), a biotechnology company focused on the emerging field of regenerative medicine, reported that it will release third quarter 2017 financial and operational results on Tuesday, November 14, 2017 after the close of the U.S. financial markets.

The Company will host a conference call and webcast on November 14, 2017 at 4:30 p.m. Eastern / 1:30 p.m. For both “listen-only” participants and those participants who wish to take part in the question-and-answer session, the call can be accessed by dialing 877-830-2645 (U.S./Canada) or 785-424-1791 (international) five minutes prior to the start of the call and providing the Conference ID 8579194. To access the live webcast, go to View Source

A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by dialing 888-203-1112 (U.S./Canada) or 719-457-0820 (international) and providing the Conference ID 8579194. Additionally, the archived webcast will be available at View Source

Aradigm Announces Third Quarter 2017 Financial Results

On November 2, 2017 Aradigm Corporation (NASDAQ: ARDM) (the “Company”) reported financial results for the third quarter and nine months ended September 30, 2017 (Press release, Aradigm, NOV 2, 2017, View Source [SID1234521472]).

The Company recorded $2.7 million in revenue in the third quarter of 2017 compared with $50,000 in revenue in the third quarter of 2016. The Company recognized $2.7 million in contract revenue – related party, $6,000 in government contract revenue and $13,000 in government grant revenue for the third quarter of 2017, as compared to $40,000 in contract revenue – related party and $10,000 in government grant revenue for the third quarter of 2016. For the third quarter of 2017, the Company recorded $1.3 million and $1.4 million in revenue under the Grifols agreement for regulatory submission services related to the filing of the NDA, and regulatory approval services related to the NDA, respectively. No revenue was recognized for these contract components in the comparable period.

Total operating expenses for the third quarter of 2017 were $5.7 million, compared with total operating expenses of $7.3 million for the third quarter of 2016. The decrease in research and development expenses of $2.3 million was due to lower contract manufacturing and clinical trial costs because the Linhaliq Phase 3 clinical trials in non-cystic fibrosis bronchiectasis (NCFBE) are complete, offset by higher employee-related expenses due to the higher number of employees and higher consulting expenses in support of the Linhaliq regulatory process towards U.S. and European Union approvals for market authorization. The increase in general and administrative expenses of $0.7 million was primarily related to higher performance bonus expense, higher legal expenses, higher non-cash stock compensation expense and higher consulting expenses.

Net loss for the third quarter of 2017 was $3.9 million or $0.26 per share, compared with a net loss of $8.2 million or $0.55 per share in the third quarter of 2016. For the quarter ended September 30, 2017, the decrease in net loss resulted primarily from an increase in revenue of $2.7 million and a decrease in operating expenses of $1.6 million.

As of September 30, 2017, the Company reported cash and cash equivalents of $12.6 million, which includes the receipt of the $5 million milestone payment received from Grifols S.A. in September 2017 for the achievement of the Linhaliq NDA filing.

“Patients with non-cystic fibrosis bronchiectasis, and especially those with chronic lung infections with Pseudomonas aeruginosa, are at risk of experiencing pulmonary exacerbations that often require interventions with antibiotics and hospitalization. Linhaliq has been developed to reduce the number of these burdensome events. Our team is working closely with the U.S. Food and Drug Administration to support them in their ongoing review of the Linhaliq NDA in order to achieve the PDUFA (Prescription Drug User Fee Act) goal date of January 26, 2018,” said Igor Gonda, President and Chief Executive Officer, Aradigm Corporation.

About Non-Cystic Fibrosis Bronchiectasis

NCFBE is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. NCFBE represents an unmet medical need with high morbidity and mortality that affects more than 150,000 people in the U.S. and over 200,000 people in Europe. NCFBE patients who have chronic infections with Pseudomonas aeruginosa have a 6.5-fold increase in hospitalization, three times higher mortality, and a worse quality of life compared with those without P. aeruginosa infections. There is currently no drug approved for the treatment of this condition.

AMAG PHARMACEUTICALS ANNOUNCES THIRD QUARTER 2017 FINANCIAL RESULTSAND BUSINESS HIGHLIGHTS

On November 2, 2017 AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) reported unaudited consolidated financial results for the quarter ended September 30, 2017 and updated its full year 2017 financial guidance (Press release, AMAG Pharmaceuticals, NOV 2, 2017, View Source [SID1234521471]).

Total GAAP revenue for the third quarter of 2017 increased to $153.7 million, 7% higher than the same period last year. The year-over-year increase was driven by sales growth across the product portfolio, including strong performance from Feraheme (ferumoxytol), which grew 17%. While third quarter sales of Makena (hydroxyprogesterone caproate) grew 5% versus the same quarter of last year, ex-factory sales were lower than anticipated due to slower-than-expected growth in underlying demand and a reduction in channel inventory. The company reported an operating loss of $249.7 million in the third quarter of 2017 due to a $319.2 million non-cash accounting charge related to the impairment of an intangible asset. This compares with operating income of $38.8 million in the same period last year. Non-GAAP adjusted EBITDA totaled $56.7 million in the third quarter of 2017, compared with $76.2 million in the third quarter of 2016.1

“Third quarter sales of Makena grew slower than forecasted, and we have updated our full year expectations accordingly. Feraheme and CBR are both on a steady growth track, and we are confirming our previous full year expectations for these products,” said William Heiden, AMAG’s president and chief executive officer. “Looking ahead, we are preparing for the potential February 2018 approval of our next generation Makena subcutaneous auto-injector and for the broader Feraheme label. We also continue to invest in the growth of our new products, and are pleased with early physician and patient response to Intrarosa and the trajectory of the launch. In addition, we are preparing to submit our NDA for bremelanotide early next year.”

Third Quarter 2017 and Recent Business Highlights:
•
Launched Intrarosa, the first and only FDA-approved locally administered non-estrogen2 product for the treatment of moderate to severe dyspareunia (pain during intercourse), a symptom of vulvar and vaginal atrophy (VVA), due to menopause:
–
Made significant formulary progress with commercial insurers and are on track to achieve 65% unrestricted coverage by year end;
–
Visited 19,000 healthcare providers at least once since launch;
–
Broadly distributed patient copay savings cards to OB/GYN offices (also available at www.intrarosa.com); and
–
More than 6,000 prescriptions written in the first 100 days;
•
AMAG’s partner, Endoceutics, Inc., initiated a Phase 3 study to assess the effectiveness of Intrarosa for the treatment of hypoactive sexual desire disorder (HSDD) in post-menopausal women;

1 See summaries of GAAP to non-GAAP adjustments at the conclusion of this press release.
2 Intrarosa is converted by enzymes in the body into androgens and estrogens, though the mechanism of action is not fully established.

1

•
Received U.S. Food and Drug Administration (FDA) acceptance for review of the Feraheme submission to broaden the current label to include the treatment of all adults with iron deficiency anemia (IDA) with a PDUFA date of February 2, 2018;
•
Feraheme abstracts selected for:
–
November 3 podium presentation (Phase 3 hypophosphatemia data) at the 2017 American Society of Nephrology (ASN) Annual Meeting in New Orleans;
–
December 11 poster presentation (Phase 3 safety and efficacy data) at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) (ASH ) Annual Meeting in Atlanta;
•
Grew Makena market share to 50%;
•
Reached 700,000 units stored at Cord Blood Registry;
•
Held a productive pre-New Drug Application (NDA) meeting with the FDA and expect to submit the NDA for bremelanotide in the first quarter of 2018;
•
Continued balance sheet optimization by reducing debt by approximately $45 million during the third quarter of 2017 and subsequent period; and
•
Ended the quarter with $394.1 million of cash and investments.

Intrarosa Launch Update
Since AMAG launched Intrarosa on July 24, the product has been prescribed by nearly 2,000 healthcare providers (HCPs), and the number of HCPs gaining clinical experience with Intrarosa is growing rapidly. During the third quarter, AMAG implemented a comprehensive copay savings program that helps ensure access to any commercially insured patient who receives an Intrarosa prescription. The program has been successful in driving rapid patient uptake regardless of formulary status. The near-term negative impact of the program on net revenue per prescription and total Intrarosa revenues (updated 2017 Intrarosa revenue guidance to between $1 million and $3 million) is anticipated to improve significantly as commercial formulary coverage continues to expand. AMAG’s current efforts focus on expanding physician awareness and education of Intrarosa, and the company expects to initiate a broad digital and social media patient engagement program in early 2018. This program will help the many women suffering from dyspareunia who are currently untreated to understand the benefits of a non-estrogen therapy and the importance of talking to their physician about their symptoms and treatment options.

Makena Intramuscular (IM) Formulation Update
While third quarter sales of Makena increased 5% year-over-year, they were lower than second quarter 2017 sales. This sequential quarter decrease was the result of a reduction in inventory related to a late second quarter inventory build, as well as slower growth in underlying demand, due in part to the adverse impact of the hurricanes in Florida and Texas. The company anticipates sales of Makena in the fourth quarter of 2017 to be lower than previously expected due to the continued impact of the reduced number of patients initiating therapy in the third quarter. Based on third quarter results and fourth quarter expectations, the company has updated 2017 Makena revenue guidance to between $385 million and $395 million.

During the third quarter of 2017, AMAG updated its long-range revenue forecast to reflect new information received from a variety of sources related to potential generic competitors to the intramuscular formulation (IM) of Makena. Based on revised long-range projections, the company determined that the current fair market value of the Makena IM intangible asset was less than its net book value, and therefore recorded a non-cash impairment charge of $319.2 million. The company also determined that the current fair value of the Makena subcutaneous auto-injector (currently under review with the FDA) was greater than its carrying value and, therefore, was not impaired.

“We believe the long-term value of the Makena franchise resides in the next generation Makena subcutaneous auto-injector,” commented Mr. Heiden. “We continue to believe that generic entry to Makena IM will likely occur in the second half of 2018, and we are prepared to implement our generic strategy earlier if necessary.”

2

Third Quarter Ended September 30, 2017 (unaudited)
Financial Results (GAAP Basis)
Total revenues for the third quarter of 2017 increased 7% to $153.7 million, compared with $143.8 million in the third quarter of 2016. Net product sales of Makena increased 5% to $97.6 million in the third quarter of 2017, compared with $93.4 million in the same period last year. Sales of Feraheme and MuGard increased 18% to $26.3 million in the third quarter of 2017, compared with $22.4 million in the third quarter of 2016. Service revenue from CBR increased 5% to $29.4 million in the third quarter of 2017, compared with $28.0 million in the same period last year.

Costs and expenses, including costs of product sales and services, totaled $403.5 million in the third quarter of 2017, compared with $105.0 million for the same period in 2016. This increase was primarily due to the $319.2 million Makena-related non-cash impairment charge, partially offset by an adjustment to contingent consideration of $49.9 million. Excluding these two accounting items, total costs and expenses increased to $134.2 million from $105.0 million in the prior year period. The increase is consistent with our previously stated plans to invest in the commercial launch of Intrarosa, including the company’s newly hired women’s health sales force and marketing programs to help drive awareness of Intrarosa. Research and development expenses decreased slightly versus the third quarter of last year. This decrease was primarily related to the completion of both the Feraheme study in support of the broader label and the Makena pharmacokinetic study for subcutaneous administration, partially offset by increased pre-NDA bremelanotide-related costs.

The impact of the non-cash impairment charge in the third quarter of 2017 contributed to an operating loss of $249.7 million in the third quarter of 2017, as compared to operating income of $38.8 million for the same period last year. The company reported a net loss of $152.1 million, or ($4.31) per basic and diluted share, for the third quarter of 2017, compared with net income of $16.2 million, or $0.47 per basic share and $0.43 per diluted share, for the same period in 2016.

Financial Results (Non-GAAP Basis)1
Non-GAAP revenue totaled $155.1 million in the third quarter of 2017, up from $145.8 million in the third quarter of 2016.

Total costs and expenses on a non-GAAP basis totaled $98.4 million in the third quarter of 2017, compared with $69.6 million in the third quarter of 2016. This increase primarily related to investments the company has made to support the commercialization of Intrarosa.

Non-GAAP adjusted EBITDA for the third quarter of 2017 was $56.7 million, resulting in an adjusted EBITDA margin of 37%. This compares to non-GAAP adjusted EBITDA of $76.2 million in the third quarter of 2016. The decline in adjusted EBITDA for the third quarter of 2017 was in line with the company’s expectations and previously stated plans to invest in the continued development and commercialization of its newer products to create long-term shareholder value.

Balance Sheet Highlights
As of September 30, 2017, the company’s cash and investments totaled $394.1 million and total debt (principal amount outstanding) was $841.4 million, net of approximately $20 million in repurchases of its convertible senior notes due in 2019. In addition, in October the company repurchased $25 million of the company’s 7.875% senior notes due in 2023.

Updated 2017 Financial Guidance
“As part of our revised full year financial guidance, we expect to mitigate the impact of reduced revenue expectations on adjusted EBITDA through disciplined expense management,” said Ted Myles, AMAG’s chief financial officer. “The company’s strong liquidity, which includes nearly $400 million of cash on hand, extended debt maturities and continued EBITDA generation, positions us well for future investment in our existing product base and additional business development to further expand our portfolio.