On August 2, 2016 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 June 30, 2016 (Press release, Corcept Therapeutics, AUG 2, 2016, http://www.corcept.com/news_events/view/pr_1470169803 [SID:1234514191]).

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Corcept reported revenue of $19.7 million and GAAP net income of $0.01 per share for the second quarter of 2016, compared to revenue of $12.0 million and a GAAP net loss of $0.02 per share for the second quarter of 2015. The company’s cash and cash equivalents were $41.8 million at June 30, 2016, an increase of $1.1 million from March 31, 2016.

The company reiterated its 2016 revenue guidance of $76-81 million.

"Our strong performance in the second quarter reflects the increasing contributions of our expanded sales force," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "Cushing’s syndrome is a complex, rare disease. Physicians often require five to seven visits before writing their first Korlym prescription. As our clinical specialists spend more time in the field and we continue to refine the support we offer physicians and patients, we are confident growth will continue."

"It is exciting to see the development of cortisol modulation advancing on so many fronts," said Robert S. Fishman, MD, Corcept’s Chief Medical Officer. "In oncology, Corcept’s activities – our now fully-enrolled trial of Korlym (mifepristone) in combination with Halaven to treat TNBC and the trial we have just begun of CORT125134 in combination with Abraxane to treat solid-tumor cancers – are supplemented by the work of leading academic investigators. Researchers at the University of Chicago, for example, are conducting two important Phase 2 trials. One, supported by Celgene Corporation, will examine the efficacy of Korlym (mifepristone) in combination with Abraxane to treat TNBC. The other combines Korlym with Xtandi (enzalutamide) to treat patients with castration-resistant prostate cancer. These trials, along with our own, will generate the data that guide our oncology program."

"Our other development programs also continue to advance," added Dr. Fishman. "Following promising pre-clinical and Phase 1 results, CORT125134 has entered Phase 2 as a treatment for Cushing’s syndrome. Our expectation is that this selective cortisol modulator will share Korlym’s efficacy as a treatment for Cushing’s syndrome patients, but without the side effects associated with Korlym’s affinity for the progesterone receptor.

"As we have stated before, we are also advancing selective cortisol modulators CORT118335, CORT122928 and CORT125281 towards the clinic and expect to initiate one or more Phase 1 trials next year."

Financial Discussion

Corcept’s GAAP net income in the second quarter of 2016 was $1.0 million, compared to a GAAP net loss of $1.9 million in the second quarter of 2015. Excluding non-cash expenses related to stock-based compensation and accreted interest on the company’s capped royalty obligation (the "Royalty Financing"), Corcept generated $3.2 million of non-GAAP net income in the second quarter of 2016, compared to non-GAAP net income of $0.4 million in the second quarter of 2015. A reconciliation of GAAP to non-GAAP net operating results is set forth below.

Operating expenses for the second quarter increased to $18.2 million, from $13.1 million in the second quarter of 2015, primarily due to additional employee compensation expense, additional patient support costs and distribution expenses resulting from higher sales volumes, and increased spending on the clinical development of CORT125134.

Corcept’s cash and cash equivalents totaled $41.8 million as of June 30, 2016, compared to $40.7 million as of March 31, 2016. These cash balances reflect Corcept’s scheduled payments made under the Royalty Financing. Pursuant to the terms of the Royalty Financing agreement, Corcept paid $3.3 million in the second quarter of 2016, compared to $3.0 million in the first quarter of 2016. Corcept expects to make its final payment under the Royalty Financing in 2017.

Conference Call

Corcept will hold a conference call on August 2, 2016, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss this announcement. To participate, dial 1-888-771-4371 from the United States or 1-847-585-4405 internationally approximately 10 minutes before the start of the call. The passcode is 42972085. A replay will be available through August 16, 2016 at 1-888-843-7419 from the United States and1-630-652-3042 internationally. The passcode is 42972085.

About Cushing’s Syndrome

Endogenous Cushing’s syndrome is caused by prolonged exposure of the body’s tissues to high levels of the hormone cortisol and is generated by tumors that produce cortisol or ACTH. Cushing’s syndrome is an orphan indication that most commonly affects adults aged 20-50. An estimated 10-15 of every one million people are newly diagnosed with this syndrome each year, resulting in over 3,000 new patients annually in the United States. An estimated 20,000 patients in the United States have Cushing’s syndrome. Symptoms vary, but most people have one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Cushing’s syndrome can affect every organ system in the body and can be lethal if not treated effectively.

About Triple-Negative Breast Cancer (TNBC)

TNBC is a form of the disease in which the three receptors that fuel most breast cancer growth – estrogen, progesterone and the HER-2/neu gene – are not present. Because the tumor cells lack the necessary receptors, treatments that target estrogen, progesterone and HER-2 receptors are ineffective. In 2013, approximately 40,000 women were diagnosed with TNBC. We estimate that more than 75 percent of these women’s tumor cells expressed the GR receptor to which cortisol binds. There is no FDA-approved treatment and neither a targeted treatment nor an approved standard chemotherapy regimen for relapsed TNBC patients exists.

About Korlym

Korlym modulates the effect of cortisol at the glucocorticoid receptor (GR), one of the two receptors to which cortisol binds, thereby inhibiting the effects of excess cortisol in patients with Cushing’s syndrome. Since 2012, Corcept has made Korlym available as a once-daily oral treatment of hyperglycemia secondary to endogenous Cushing’s syndrome in adult patients with glucose intolerance or diabetes mellitus type 2 who have failed surgery or are not candidates for surgery. Korlym was the first FDA-approved treatment for that illness. The FDA has designated it as an Orphan Drug for that indication.

About CORT125134

CORT125134 is the lead compound in Corcept’s portfolio of selective cortisol modulators. It is a non-steroidal competitive antagonist of GR that does not bind to the body’s other hormone receptors, including the progesterone receptor. It is the affinity of Korlym for the progesterone receptor that results in termination of pregnancy and can cause endometrial thickening and irregular vaginal bleeding in some women. CORT125134 will not have these effects. Corcept is currently studying the compound in two Phase 2 trials, one for the treatment of patients with Cushing’s syndrome and another for patients suffering from solid-tumor cancers. CORT125134 is proprietary to Corcept and is protected by composition of matter and method of use patents extending to 2033.

On August 2, 2016 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Allergan plc (NYSE: AGN) reported that Teva has completed its acquisition of Allergan’s generics business ("Actavis Generics") (Press release, Teva, AUG 2, 2016, View Source;p=irol-newsArticle&ID=2191986 [SID1234516257]).

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This strategic acquisition brings together two leading generics businesses with complementary strengths, R&D capabilities, product pipelines and portfolios, geographical footprints, operational networks and cultures. The result is a stronger, more competitive Teva, well positioned to thrive in an evolving global marketplace, to realize the opportunities the very attractive global and U.S. generics markets offer, and to deliver the highest-quality generic medicines at the most competitive prices, unlocking value to patients, healthcare systems and investors around the world.

"The acquisition of Actavis Generics comes at a time when Teva is stronger than ever—in both our generics and specialty businesses," said Erez Vigodman, President and CEO, Teva. "Through our acquisition of Actavis Generics, we are creating a new Teva with a strong foundation, significantly enhanced financial profile and more diversified revenue sources and profit streams backed by strong product development engines in both generics and specialty. This is a platform that is expected to generate multi-year top-line and bottom-line growth as well as significant cash flow."

Mr. Vigodman continued, "We are confident that we can realize the projected synergies and accretion inherent in this acquisition for our stockholders and quickly integrate Actavis Generics into Teva. Furthermore, as a result of our strengthened financial profile following this transaction, we will be even better positioned to reap the benefits of Teva’s R&D capabilities to support top-line growth and expand our portfolio across the business. The strong, combined company cash flow will allow for rapid deleveraging and give us the ability to continue capital allocation, with a focus on bolstering our specialty pipeline and product portfolio as well as strengthening shareholder returns."

With the acquisition, Teva now has approximately 338 product registrations pending FDA approval and holds the leading position in first-to-file opportunities with approximately 115 pending ANDAs in the U.S. In Europe, after divestitures; Teva will have a pipeline capable of over 5000 launches across the region. In Teva growth markets including, Asia, Africa, Latin America, Middle East, Russia and CIS, there are now approximately 600 pending product approvals. Overall, Teva is planning for 1,500 generic launches globally in 2017.

Teva’s products generated approximately $215 billion in savings in the last decade to the U.S. healthcare system; this number will continue to increase and even accelerate as a result of the acquisition.

"Teva now has some of the best assets, people and capabilities in the industry. We have a clear responsibility to turn those strengths into meaningful results for patients, customers and the communities we serve, as well as for our shareholders," said Siggi Olafsson, President and CEO, Global Generic Medicines, Teva. "We are pleased to welcome our talented new colleagues from Actavis Generics, including many first-class scientists and business leaders."

Increased Global Commercial Reach
Teva’s acquisition of Actavis Generics improves international commercial opportunities and significantly enhances the global scale of its sales and R&D platforms. Offering access to the world’s largest drug cabinet—with more than 1,800 medicines and 16,000 products—Teva now has a commercial presence across 80 markets, including a top-three leadership position in over 40 markets and global leadership in all key global markets.

Financial Highlights
Teva expects to achieve cost synergies and tax savings of approximately $1.4 billion annually by the end of 2019, by eliminating duplication and inefficiencies on a global scale and capturing economies of scale.
Allergan plc received $33.43 billion in cash and approximately 100 million Teva shares.
Strong Combined Global Leadership Team and Employees with Deep Experience across the Business

The two companies share a close cultural and strategic fit, and Teva is focused on leveraging both organizations’ competencies and talent. The combined company’s expanded senior management team is comprised of leaders from both Teva and Actavis. It is structured to leverage the strong talent from both organizations to ensure that the new company capitalizes on its expanded global commercial footprint and Teva’s continued strength as a world leader in generics. With this structure in place beginning on Day One, the company is immediately positioned to maximize growth across all of its global businesses.
Operational Integration and Readiness

Since the acquisition agreement was announced in July 2015, integration teams at Teva and Actavis Generics have worked diligently to plan for integration of the two companies in order to ensure that the combined company is fully operational immediately upon the closing of the transaction. As a result of these actions, Teva will begin to capitalize on the benefits offered by the acquisition of Actavis Generics starting immediately.

"Our ability to close a transaction of this size successfully and be operational on ‘Day One’ is a true testament to the dedication of the integration planning teams at both companies," said Richard Daniell, Teva Chief Integration Officer. "Because business continuity was a primary objective throughout the integration process, our leaders and colleagues are in a position to quickly build on Teva’s solid financial foundation, operational discipline and diverse product base to continue to improve our performance."

On August 2, 2016 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, reported financial results for the three and six months ended June 30, 2016 and provided a summary of corporate highlights (Press release, Regulus, AUG 2, 2016, View Source [SID:1234514193]).

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Regulus Therapeutics Inc. Logo
"The second quarter was very busy from both the clinical and corporate perspectives," said Paul Grint, MD, Regulus’ President and Chief Executive Officer. "We remain on track to deliver follow-up results from RG-101 studies while working to address the deficiencies outlined in the clinical hold letter from the FDA. In addition, we are initiating a Phase II study in Alport Syndrome for RG-012, and plan to nominate our fourth clinical candidate by year-end."

Financial Results

Revenue: Revenue was $0.5 million and $1.0 million for the three and six months ended June 30, 2016, respectively, compared with $3.8 million and $8.0 million for the same periods in 2015. Revenue for the three and six months ended June 30, 2016 and 2015 consisted of amortization of up-front payments from Regulus’ strategic alliances and collaborations. Revenue for the three months ended June 30, 2015 included $2.6 million for research services under Regulus’ strategic alliances and collaborations. Revenue for the six months ended June 30, 2015 included $3.2 million for research services and $2.9 million in pre-clinical and other milestones under Regulus’ strategic alliances and collaborations.

Research and Development (R&D) Expenses: R&D expenses were $18.0 million and $34.8 million for the three and six months ended June 30, 2016, respectively, compared with $19.2 million and $32.6 million for the same periods in 2015. R&D expenses were consistent for the three months ended June 30, 2016 and 2015, excluding non-recurring severance charges recorded in June 2015. The increase for the six months ended June 30, 2016 was driven by an increase in our aggregate clinical trial program costs.

General and Administrative (G&A) Expenses: G&A expenses were $3.7 million and $8.8 million for the three and six months ended June 30, 2016, respectively, compared with $5.8 million and $9.5 million for the same periods in 2015. These decreases were primarily driven by non-recurring severance charges recorded in June 2015, partially offset by an increase in recurring personnel costs for the three and six months ended June 30, 2016.

Net Loss: Net loss was $21.1 million, or $0.40 per share, and $42.3 million, or $0.80 per share, for the three and six months ended June 30, 2016, respectively, compared with a net loss of $21.0 million, or $0.41 per share, and $35.5 million, or $0.70 per share, for the same periods in 2015.

Cash Position: Cash, cash equivalents and short-term investments were $108.0 million as of June 30, 2016, compared with $106.0 million at March 31, 2016.

Highlights and Recent Events

In July, as anticipated, Regulus received a formal clinical hold letter from the FDA outlining information required to address the clinical hold for the IND of RG-101, which was announced in late June. The FDA initiated the clinical hold after the company reported a second serious adverse event (SAE) of jaundice. This second SAE occurred in a HCV patient with end-stage renal disease on dialysis enrolled in its on-going Phase I US study.
In June, Regulus secured a $30.0 million growth capital credit facility with Oxford Finance LLC and received $20.0 million at closing under an initial term loan. An additional $10.0 million will be available subject to the achievement of a certain specified milestone. The loans provide for interest-only payments for the first 24 months of the term, and will bear interest at a rate equal to the sum of 8.51% plus the greater of 0.44% or the 30-day LIBOR rate.
In June, Regulus reported positive top-line data from the primary endpoint analysis of our Phase II "closed-face sandwich" study, which demonstrated significant virologic response through 24 weeks of follow-up.
In May, Regulus expanded the clinical trial collaboration agreement with GSK to conduct a multi-centered, randomized, dose-ranging Phase II study evaluating the combination of RG-101 and GSK’s long-acting parenteral ("LAP") formulation of GSK2878175 as a potential single-visit cure in patients chronically infected with HCV.
In May, Regulus presented preclinical and longitudinal data from ATHENA, a natural history of disease study in patients with Alport Syndrome, at the ERA-EDTA 53rd Congress.

vTv Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, vTv Therapeutics, 2017, AUG 2, 2016, View Source [SID1234521331]).

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On August 02, 2016 Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported financial results for second quarter 2016 and associated company developments (Press release, Supernus, AUG 2, 2016, View Source [SID:1234514195]).

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Commercial Update

Second quarter 2016 product prescriptions for Trokendi XR and Oxtellar XR, as reported by IMS, totaled 123,758, a 38.9% increase over the second quarter of 2015.

Prescriptions
Q2 2016 Q1 2015 Change %

Trokendi XR 93,094 65,552 42.0 %
Oxtellar XR 30,664 23,534 30.3 %

Total 123,758 89,086 38.9 %

Source: IMS

Total revenue for the second quarter of 2016 was $50.4 million, a 43.8% increase over $35.1 million in the same period last year. Total revenue for both periods consisted almost exclusively of net product sales.

Net Product Sales ($mil.)
Q2 2016 Q2 2015 Change %

Trokendi XR $ 37.6 $ 26.3 43.3 %
Oxtellar XR $ 12.7 $ 8.0 58.7 %

Total $ 50.3 $ 34.3 46.9 %

"We are pleased with the growth in prescriptions and net product sales in the second quarter and through the first half of 2016. For the first six months of 2016, net product sales increased approximately 50%, as compared to the same period last year," said Jack Khattar, President and CEO of Supernus Pharmaceuticals. "The solid growth in prescriptions behind our products three years post launch reinforces our belief that the combined annual peak sales for Oxtellar XR and Trokendi XR can exceed $500 million."

In June 2016 the Company submitted the revised label for Trokendi XR requesting approval to expand the label to include treatment of migraine in adults. As previously announced, this resubmission was requested by the Food and Drug Administration (FDA) to review the proposed label in a different format. The FDA has set a target date in the third quarter of 2016 to complete its review. We continue to prepare and will be ready to launch the migraine indication soon after receiving full FDA approval.

Progress of Product Pipeline

Enrollment continues for both Phase III trials for SPN-810, which is currently in development for Impulsive Aggression in patients aged 6 to 12 years who have ADHD. The pace of enrollment is slower than anticipated due to challenges such as those experienced by caregivers in recording patient information on the new electronic diary, and lack of compliance during the screening period regarding ‘washing out’ of current medications. As a consequence, we have instituted a number of measures to improve patient enrollment and retention. These include lengthening the screening period to provide increased education for site coordinators and caregivers on the electronic diary and to make it easier for caregivers and patients to comply with the trial protocol. Although the pace of recruitment has picked up recently for both Phase III trials, it is likely that enrollment will continue into 2017. The Company continues to expect to launch SPN-810 in 2019. During the third quarter of 2016, patients began enrolling into the open-label extension portion of the Phase III study.

Regarding SPN-812, currently in development for patients aged 6 to 12 years with ADHD, the Phase IIb trial is now fully recruited. The final patient visit was completed during the third quarter of 2016. Eligible patients are now entering the open label extension portion of the study. The Company continues to expect data from the SPN-812 Phase IIb trial to be available by early 2017.

"With the SPN-812 Phase IIb trial fully enrolled, we have reached another important clinical milestone as we continue to advance SPN-812 into late-stage development," said Jack Khattar. "Regarding SPN-810, we are encouraged by the recent progress in improving recruitment and retention, and we remain focused on the successful execution of the trials."

Mr. Khattar added, "We believe the 84% rate of enrollment into the open-label extension of the Phase IIb study for SPN-812 reflects a high level of satisfaction from physicians and patients."

Operating Expenses

Research and development expenses in the second quarter of 2016 were $11.1 million, as compared to $6.9 million in the same quarter last year. This increase is primarily due to the ongoing Phase III testing of SPN-810 and Phase IIb testing of SPN-812, as well as the open-label extension studies associated with both SPN-810 and SPN-812.

Selling, general and administrative expenses in the second quarter of 2016 were $26.1 million, as compared to $23.3 million in the same quarter last year. The increase is primarily due to the efforts in preparing for the launch of the migraine indication for Trokendi XR.

Operating Income and Earnings Per Share

Operating income in the second quarter of 2016 was $10.4 million, as compared to $3.1 million in the same period last year. This improvement in operating income is primarily due to increased net product sales.

Diluted earnings per share were $0.18 in the second quarter of 2016, as compared to $0.03 in the same period last year.

Weighted-average diluted common shares outstanding were approximately 51.7 million in the second quarter of 2016, as compared to approximately 52.3 million in the same period last year.

Capital Resources

As of June 30, 2016, the Company had $128.0 million in cash, cash equivalents, marketable securities, and long term marketable securities, as compared to $117.2 million at December 31, 2015. As of June 30, 2016, approximately $6.6 million of the Company’s six year, $90 million notes, bearing interest at 7.5% per annum, remain outstanding.

Financial Guidance

For full year 2016, the Company is reiterating guidance for net product sales and adjusting guidance for R&D expenses and operating income as set forth below:

Net product sales will remain in the range of $200 million to $210 million.
R&D expenses in the range of $50 million to $55 million, compared to the previously expected range of $55 million to $65 million.
Operating income in the range of $32 million to $37 million, compared to the previously expected range of $28 million to $35 million.