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11/05/2015 Corcept Therapeutics Announces Third Quarter 2015 Results and Provides Corporate Update

On November 5, 2015 Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical company engaged in the discovery, development and commercialization of drugs that treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported its financial results for the quarter ended September 30, 2015 and provided a corporate update (Press release, Corcept Therapeutics, NOV 5, 2015, http://www.corcept.com/news_events/view/pr_1446758532 [SID:1234508043]).

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Corcept recorded net revenue of $13.3 million in the third quarter of 2015, compared to $7.3 million for the same period in 2014, an increase of 82 percent. The company reiterated its 2015 revenue guidance of $49 – $53 million.

Corcept reported a net loss on a GAAP basis of $0.6 million for the third quarter of 2015, compared to a GAAP net loss of $6.0 million for the same period in 2014. Excluding non-cash expenses, Corcept generated non-GAAP net income in the third quarter of $1.6 million, compared to a non-GAAP net loss of $3.9 million in the third quarter of 2014. A reconciliation of GAAP to non-GAAP net operating results is set forth below.

At September 30, 2015, Corcept held cash and cash equivalents of $36.5 million, compared to $37.0 million at the end of the prior quarter. This change in cash reflects the repayment of $1.8 million in principal due under the company’s capped royalty financing agreement (Royalty Financing). The company entered into the Royalty Financing in 2012 to fund the commercialization of Korlym and expects to make its final payment in 2017.

Based on its current plans, the company expects to reach cash flow breakeven, including payments of principal due under the Royalty Financing, without needing to raise additional funds.

"Our Cushing’s syndrome franchise continues to grow as more physicians appreciate that using Korlym to modulate the effect of excess cortisol can greatly improve their patients’ health," said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer. "As we have said before, our efficient cost structure and the revenue growth in our Cushing’s syndrome business allows us to build our clinical infrastructure, further develop Korlym and advance our next-generation compounds."

Korlym for the Treatment of Triple-Negative Breast Cancer (TNBC)

In December 2015, at the San Antonio Breast Cancer Symposium, Corcept will present preliminary efficacy results of its Phase 1/2 open-label trial of Korlym in combination with eribulin (Halaven) to treat patients with metastatic TNBC.

CORT125134 Phase 2 Trials

CORT125134 is the lead compound in Corcept’s portfolio of proprietary next-generation cortisol modulators. It was well-tolerated in its Phase 1 trial and showed that it shares Korlym’s ability to potently modulate activity at the glucocorticoid receptor (GR), the essential quality in treating Cushing’s syndrome. In addition, when administered with a chemotherapeutic agent, CORT125134 slows tumor growth significantly in mouse models of TNBC and castration-resistant prostate cancer. In vitro, it similarly slows the growth of ovarian cancer tumor cells; in vivo testing in mouse models of ovarian cancer is in progress.

In the first quarter of 2016, the company plans to begin two Phase 2 clinical trials with CORT125134. One trial will be for the treatment of patients with Cushing’s syndrome. The other will administer CORT125134 with a companion chemotherapeutic or hormonal agent to treat patients with a solid tumor cancer.

"It’s an exciting time to join Corcept," said Robert S. Fishman, M.D., Corcept’s Chief Medical Officer. "We are exploring extending Korlym’s label to cover oncologic indications, our lead next-generation cortisol modulator, CORT125134, is about to enter multiple Phase 2 trials and we’re advancing additional selective cortisol modulating compounds toward the clinic."

Financial Discussion

Corcept recorded a GAAP net loss of $0.6 million in the third quarter of 2015, compared to $6.0 million in the third quarter of 2014, including non-cash stock-based compensation and accreted interest expense generated from the Royalty Financing of $2.2 million and $2.1 million in the third quarter of 2015 and 2014, respectively. Excluding these non-cash items, Corcept generated net income on a non-GAAP basis of $1.6 million in the third quarter of 2015, compared to a non-GAAP net loss of $3.9 million in the third quarter of 2014.

Operating expenses for the third quarter were $13.2 million, compared to $12.4 million for the third quarter of 2014. The increase was primarily due to increased staffing costs and additional spending on the Phase 1/2 trial of Korlym for the treatment of TNBC and the development of next-generation cortisol modulators.

In the third quarter of 2015, Corcept made a payment of $2.5 million under the Royalty Financing, of which $0.7 million represented accreted interest and $1.8 million reduced outstanding principal. In the same period of 2014, Corcept paid $1.3 million, of which $0.9 million represented accreted interest and $0.4 million reduced outstanding principal. Corcept expects to make its final payment under the Royalty Financing in 2017.

Corcept’s cash balance at September 30, 2015 was $36.5 million, compared to $37.0 million at June 30, 2015 and $24.2 million at December 31, 2014.

Cellectis to Present Data on its Allogeneic CAR T-Cell Immunotherapy Product Candidates during the Upcoming ASH Annual Meeting

On November 5, 2015 Cellectis (Alternext: ALCLS – Nasdaq: CLLS) reported that data on its engineered allogeneic CAR T-Cell product candidates, UCARTCS1 and UCART123, will be presented during the 2015 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Cellectis, NOV 5, 2015, View Source [SID:1234508042]). A poster and an oral presentation will be presented during this event.

Bypassing the Constraint for Chimeric Antigen Receptor (CAR) Development in T-Cells Expressing the Targeted Antigen: Improvement of Anti-CS1 CAR Activity in Allogenic TCRa/CS1 Double Knockout T-Cells for the Treatment of Multiple Myeloma (MM)
Oral presentation

Session Name: Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Novel Immunotherapeutics and the Impact of the Microenvironment

Presentation Time: Saturday, December 5, 2015 at 2:15 PM

TCRab Deficient CAR T-Cells Targeting CD123: An Allogeneic Approach of Adoptive Immunotherapy for the Treatment of Acute Myeloid Leukemia (AML)
Poster presentation

Session Name: Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster II

Presentation Time: Sunday, December 6, 2015 from 6:00 PM to 8:00 PM

Oncothyreon Reports Third Quarter 2015 Financial Results

On November 05, 2015 Oncothyreon Inc. (NASDAQ:ONTY) reported financial results for the third quarter ended September 30, 2015 (Press release, Oncothyreon, NOV 5, 2015, View Source [SID:1234508037]).

Net loss for the three months ended September 30, 2015 was $4.6 million, or $0.05 per basic and diluted share, compared with a net loss of $6.7 million, or $0.09 per basic and diluted share, for the comparable period in 2014. The $2.1 million decrease in net loss was attributable to the difference in the change in the fair value of warrant liability of $1.3 million. The decrease in net loss was also due to decreases in research and development expenses of $0.5 million and decreases in general and administrative expenses of $0.3 million.

Net loss for the nine months ended September 30, 2015 was $23.5 million, or $0.24 per basic and diluted share, compared with a net loss of $22.4 million, or $0.31 per basic and diluted share, for the comparable period in 2014. The $1.1 million increase in net loss was attributable to the difference in the change in the fair value of warrant liability of $0.4 million and increases in research and development expenses of $0.7 million.

Oncothyreon’s cash, cash equivalents and investments totaled $63.7 million as of both September 30, 2015 and December 31, 2014.

Financial Guidance

Oncothyreon believes the following financial guidance to be correct as of the date provided. Oncothyreon is providing this guidance as a convenience to investors and assumes no obligation to update it.

Oncothyreon currently expects operating expenses in 2015 to be lower than in 2014, which included the upfront payment to Array BioPharma Inc. for the exclusive license to ONT-380. Oncothyreon currently expects cash used in operations in 2015 to be approximately $30.0 – $32.0 million.

Nektar Therapeutics Reports Financial Results for the Third Quarter of 2015

On November 5, 2015 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the third quarter ended September 30, 2015 (Press release, Nektar Therapeutics, NOV 5, 2015, View Source [SID:1234508036]).

Cash and investments in marketable securities at September 30, 2015 were $267.8 million as compared to $279.7 million at June 30, 2015. Cash and investments at September 30, 2015 include a $40.0 million milestone payment received from AstraZeneca in Q3 2015 for the first commercial sale of MOVENTIG (naloxegol) in Germany. Cash and investments at September 30, 2015 do not include the proceeds from the $250 million direct private placement of 7.75% Senior Secured Notes due in 2020, which was closed on October 5, 2015. A portion of the proceeds from these new $250 million Senior Notes were used to redeem fully $125.0 million of 12% Senior Secured Notes due in 2017.

"We have made great progress in advancing our pipeline this year," said Howard W. Robin, President and Chief Executive Officer of Nektar. "MOVANTIK is performing very well with positive feedback from physicians and patients, ADYNOVATE is poised for approval, the NKTR-181 Phase 3 SUMMIT-07 efficacy study is enrolling ahead of schedule and we are exceptionally pleased to report that the FDA cleared the NKTR-214 IND earlier than anticipated. NKTR-214 has the potential to bring a new mechanism – direct and selective stimulation of a patient’s cancer-fighting T-cells — to the next generation of cancer immunotherapies. We expect to dose our first patients shortly at MD Anderson Cancer Center and Yale Cancer Center."

Year-to-date revenue for 2015 was $191.4 million as compared to $181.2 million in the first nine months of 2014. The increase in revenue in the first nine months of 2015 as compared to the same period in 2014 includes the recognition of $90.0 million of the $100.0 million milestone payment from AstraZeneca following the first commercial sale of MOVANTIK in the U.S. and the recognition of the $40.0 million milestone payment from AstraZeneca following the first commercial sale of MOVANTIK in a major European country. In addition, product sales and royalty revenue increased by $9.3 million in the first nine months of 2015 as compared to the same period in 2014. Revenue in the third quarter of 2015 was $60.0 million as compared to $132.9 million in the third quarter of 2014 due to the recognition of a one-time $105 million approval milestone for MOVANTIK in the third quarter of 2014.

Total operating costs and expenses in the third quarter of 2015 were $59.5 million as compared to $52.6 million in the third quarter of 2014. Year-to-date total operating costs and expenses in 2015 were $191.4 million as compared to $160.2 million for the same period in 2014. Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.

Research and development expense in the third quarter of 2015 was $43.2 million as compared to $34.2 million in the third quarter of 2014. Year-to-date R&D expense for 2015 was $135.7 million as compared to $109.2 million for the same period in 2014. R&D expense was higher in the third quarter and first nine months of 2015 as compared to the same periods in 2014 primarily due to the initiation of the Phase 3 efficacy trial of NKTR-181 in chronic low back pain and the long-term safety study for NKTR-181. R&D expense for the first nine months of 2015 also increased as a result of IND-enabling and clinical study start-up activities for NKTR-214.

General and administrative expense was $9.5 million in the third quarter of 2015 as compared to $9.1 million in the third quarter of 2014. G&A expense in the first nine months of 2015 was $30.0 million as compared to $28.7 million for the same period in 2014.

Net loss in the third quarter of 2015 was $8.2 million or $0.06 net loss per diluted share as compared to net income of $70.6 million or $0.53 net income per diluted share in the third quarter of 2014. Net loss in the first nine months of 2015 was $27.0 million or $0.21 net loss per diluted share as compared to net loss of $8.2 million or $0.07 net loss per diluted share in the first nine months of 2014.

The company also announced upcoming presentations at the following scientific congresses during the fourth quarter of 2015:

Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) 30th Anniversary Annual Meeting, National Harbor, MD:

Abstract Title: "Synergistic antitumor activity of the CD122-biased immunostimulatory cytokine NKTR-214 when combined with anti-PD-1 in murine tumor models", Hoch, U., et al.
Date: November 6, 2015, 12:45 p.m. — 2:00 p.m. Eastern Time

2015 San Antonio Breast Cancer Symposium, San Antonio, TX:

Poster P1-13-02: "Early change in topoisomerase 1 (Top1) positive circulating tumor cells (CTCs) is associated with overall survival (OS) in patients with advanced breast cancer after treatment with etirinotecan pegol", Rugo, H., et al.
Poster Session: Advanced Chemotherapy
Date: December 9, 2015, 5:00 p.m. – 7:00 p.m. Central Time

Poster P4-11-08: "Impact of treatment on quality of life (QOL) in the BEACON study, a randomized phase III trial of etirinotecan pegol (EP) versus Treatment of Physician’s Choice (TPC) in patients (pts) with advanced breast cancer (aBC) whose disease has progressed following treatment with an Anthracycline, a Taxane and Capecitabine", Cortes, J., et al.
Poster Session: "Psychosocial, Quality of Life, and Educational Aspects: Psychosocial, QOL, and Educational Aspects — Other"
Date: December 11, 2015, 7:30 a.m. — 9:00 a.m. Central Time

Medivation Reports Third Quarter 2015 Financial Results

On November 5, 2015 Medivation, Inc. (NASDAQ: MDVN) reported its financial results for the third quarter ended September 30, 2015. U.S. net sales of XTANDI (enzalutamide) capsules, as reported by Astellas Pharma Inc, were $313.0 million for the quarter (+73% vs. prior year) (Press release, Medivation, NOV 5, 2015, View Source [SID:1234508035]). Third quarter 2015 U.S. net sales increased by approximately 5% compared with second quarter 2015 net sales of $298.4 million. The sequential quarter increase in net sales was primarily due to an increase in underlying demand (mid-single digit percent growth, compared with June 2015 quarter) and a lower gross-to-net rate recorded by Astellas in the third quarter, which was offset by changes in channel partner inventory levels during the quarters.

Ex-U.S. net sales of XTANDI, as reported by Astellas, were approximately $205 million for the quarter (+71% vs. prior year). Third quarter ex-U.S. net sales increased by 9% compared with second quarter 2015 net sales of approximately $188 million.

"During the third quarter Medivation made significant progress led by continued demand growth for XTANDI for the treatment of metastatic castration-resistant prostate cancer," said David Hung, M.D., president and chief executive officer of Medivation. "In October, we successfully completed the acquisition for the late stage asset talazoparib, a highly-potent, orally-available poly ADP ribose polymerase (PARP) inhibitor. With the acquisition of talazoparib, we now have further diversified our late-stage pipeline beyond XTANDI and pidilizumab to complement our early development programs, providing significant opportunities for growth."

Medivation reported GAAP net income of $79.5 million, or $0.47 per diluted share, for the quarter ended September 30, 2015, compared with GAAP net income of $78.0 million, or $0.48 per diluted share, for the same period in 2014. Non-GAAP net income for the third quarter of 2015 was $58.4 million, or $0.35 per diluted share, compared with non-GAAP net income of $16.3 million, or $0.10 per diluted share, for the same period in 2014.

Medivation’s collaboration revenue for the third quarter of 2015 was $260.7 million on a GAAP basis compared with $200.5 million for the same period in 2014 (+30% vs. prior year). Non-GAAP collaboration revenue, which excludes collaboration revenue related to upfront and milestone payments, was $190.1 million for the third quarter compared with $106.2 million for the same period in 2014 (+79% vs. prior year).

Medivation’s collaboration revenue consists of three components: collaboration revenue related to U.S. XTANDI net sales, collaboration revenue related to ex-U.S. XTANDI net sales, and collaboration revenue related to upfront and milestone payments.

Medivation’s collaboration revenue related to U.S. net sales of XTANDI for the third quarter 2015 was $156.5 million compared with $90.7 million for the same period in 2014 (+73% vs. prior year).

Medivation’s collaboration revenue related to ex-U.S. net sales of XTANDI for the third quarter 2015 was $33.6 million compared with $15.5 million for the same period in 2014 (+116% vs. prior year).

Medivation’s collaboration revenue related to upfront and milestone payments for the third quarter 2015 was $70.6 million compared with $94.2 million for the same period in 2014 (-25% vs. prior year).

Operating expenses were $121.7 million for the quarter ended September 30, 2015 on a GAAP basis compared with $108.6 million for the same period in 2014. Non-GAAP operating expenses were $98.8 million for the quarter ended September 30, 2015 compared with $79.3 million for the same period in 2014.

Selling, general and administrative (SG&A) expenses for the third quarter of 2015 were $75.8 million on a GAAP basis compared with $63.2 million for the same period in 2014. Non-GAAP SG&A expenses for the third quarter of 2015 were $58.8 million, compared with $47.5 million for the same period in 2014. The increase in non-GAAP SG&A expenses primarily relates to higher sales, marketing, administrative expenses, higher royalties to UCLA and higher personnel-related costs (excluding stock-based compensation).

Research and development (R&D) expenses for the third quarter of 2015 were $45.9 million on a GAAP basis compared with $45.4 million for the same period in 2014. Non-GAAP R&D expenses for the third quarter of 2015 were $40.0 million, compared with $31.8 million for the same period in 2014. The increase in non-GAAP R&D expenses primarily relates to higher pidilizumab (MDV9300) costs, higher facilities and information technology costs and higher personnel-related costs (excluding stock-based compensation).

At September 30, 2015, cash and cash equivalents were $488.9 million, compared with $502.7 million at December 31, 2014. During the third quarter, we completed the redemption of the 2017 Convertible Notes, utilizing $167.8 million of cash. In October 2015, we utilized $410.0 million in cash to fund an upfront payment to BioMarin Pharmaceutical Inc., for the acquisition of talazoparib (MDV3800).

Enzalutamide Development Program

Reported updated data in September 2015 from a Phase 2 trial evaluating the investigational use of enzalutamide as a single agent for the treatment of advanced androgen receptor positive, triple-negative breast cancer at the 2015 European Cancer Congress.

Recent Corporate Developments

Closed the acquisition on October 6, 2015, for all worldwide rights to talazoparib, an orally-available poly ADP ribose polymerase (PARP) inhibitor. In connection with the closing, Medivation made an up-front payment of $410.0 million to BioMarin in the fourth quarter of 2015. All other amounts to be paid to BioMarin in connection with this transaction will be subject to the successful achievement of certain regulatory and sales-based milestones and royalties relating to talazoparib.

Effected a two-for-one stock split in the form of a stock dividend on Medivation’s common stock, pursuant to which stockholders of record on August 13, 2015, received an additional share of common stock for each share they held as of the record date. Approximately 81.7 million common shares were issued as a result of the stock dividend in mid-September. Medivation’s common stock began trading on a post-dividend basis on the NASDAQ Global Select Market at the opening of trading on September 16, 2015.

Entered into a Credit Agreement with JPMorgan Chase Bank, N.A., as administrative agent, and the lenders, providing for a one-year $75.0 million revolving loan facility. On September 17, 2015, Medivation executed a borrowing of $75.0 million under the Revolving Credit Facility, which was scheduled to mature on March 17, 2016. On October 23, 2015, Medivation entered into an amendment and restatement of the credit agreement providing for a five-year $300.0 million revolving loan facility and an uncommitted accordion facility subject to the satisfaction of certain conditions. On October 23, 2015, Medivation borrowed $75.0 million under the amended revolving credit facility, which was used to repay the $75.0 million outstanding under the original credit agreement.

Announced the appointment of Mohammad Hirmand, M.D., as interim chief medical officer following the retirement of Lynn Seely, M.D.