On July 27, 2015 MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX, OTC: MPSYY) reported its financial results for the six months ending 30 June 2015. Group revenues were EUR 82.6 million (H1 2014: EUR 30.5 million) (Press release, MorphoSys, JUL 26, 2015, View Source [SID:1234506699]). The increase is attributable to revenue booked in connection with the ending of the collaboration with Celgene on MorphoSys’s proprietary drug candidate MOR202. This comprised the full realization of deferred revenues from an up-front payment received from Celgene in 2013 together with a one-time termination payment. Earnings before interest and taxes (EBIT) amounted to EUR 46.1 million (H1 2014: EUR 0.4 million). On 30 June 2015, MorphoSys held cash and cash equivalents, marketable securities, and financial assets classified as loans and receivables of EUR 324.9 million in comparison to EUR 352.8 million on 31 December 2014.

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Highlights of the Second Quarter 2015

At the end of the second quarter of 2015, MorphoSys’s product pipeline comprised a total of 102 therapeutic antibodies, including 24 clinical programs. Three partnered programs are currently in phase 3 trials.

MorphoSys presented its updated phase 2 clinical results for MOR208 in non-Hodgkin’s lymphoma (NHL) at the 2015 annual conference of the American Society of Oncology (ASCO) (Free ASCO Whitepaper). The clinical data showed that MOR208 is well tolerated with a low level of infusion reactions and demonstrated encouraging single-agent activity.

MorphoSys also presented preliminary clinical data on the safety, pharmacokinetics and efficacy of MOR202 in multiple myeloma at the 2015 ASCO (Free ASCO Whitepaper) conference. MOR202 proved to be safe and well tolerated and showed early signs of clinical activity and cases of long-lasting tumor control.

In May 2015, MorphoSys acquired all outstanding shares in the Dutch biopharmaceutical company Lanthio Pharma. The acquisition added new development candidates to MorphoSys’s proprietary portfolio, including a preclinical program for fibrotic diseases (MOR107).

In April 2015, MorphoSys announced that it had reached a clinical milestone with the initiation of a phase 2 study of the antibody guselkumab in psoriatic arthritis by its partner Janssen Biotech. The milestone payment was recognized in the first quarter of 2015.
Shortly after the end of the second quarter, MorphoSys announced that it had reached a clinical milestone associated with the IND filing of an antibody being developed to treat blood disorders by its partner Novartis, which was recognized in the second quarter of 2015.

At the Annual General Meeting on 8 May 2015, Ms. Wendy Johnson, Mr. Klaus Kühn and Dr. Frank Morich were newly elected to the Supervisory Board. Dr. Gerald Möller, Dr. Marc Cluzel and Ms. Karin Eastham were all re-elected to the Supervisory Board. Additionally, all resolutions proposed by the management were adopted.

MorphoSys repurchased 88,670 of its own shares in the second quarter of 2015. The shares will be used primarily for long-term incentive programs for the Management Board and Senior Management Group.

"The second quarter saw excellent progress with regard to our proprietary pipeline and the further expansion of our drug development capabilities in the biologics arena beyond antibodies. Clearly the highlight of the quarter from a pipeline perspective was the presentation of encouraging clinical data for our most advanced proprietary oncology programs MOR208 and MOR202," stated Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG.

"We are very pleased with the first half of 2015 and are on track to meet our goals for the full year. The addition of Lanthio’s portfolio of therapeutic peptides to our pipeline combined with new therapeutic antibody programs initiated by our partners have increased the number of therapeutic candidates in different stages of development for the first time beyond the 100 program mark," commented Jens Holstein, Chief Financial Officer of MorphoSys AG.

Financial Review for the First Half of 2015 (IFRS)

Group revenues for the first six months of 2015 amounted to EUR 82.6 million (H1 2014: EUR 30.5 million). Reasons for the increase were one-time effects in H1 2015 in connection with the full realization of deferred revenues from an up-front payment received from Celgene in 2013 together with a one-time termination fee. The Proprietary Development segment recorded revenues of EUR 59.6 million (H1 2014: EUR 7.7 million), all of which were recorded in connection with the co-development agreement with Celgene. Revenues in the Partnered Discovery segment comprised EUR 21.0 million in funded research and licensing fees (H1 2014: EUR 21.4 million) and EUR 2.0 million in success-based payments (H1 2014: EUR 1.4 million).

Total operating expenses for the first six months of 2015 amounted to EUR 40.9 million (H1 2014: EUR 30.1 million). Total research and development expenses were EUR 33.9 million (H1 2014: EUR 23.4 million). R&D expenses mainly consisted of costs for external lab services and personnel costs. Expenses for proprietary product and technology development amounted to EUR 25.3 million (H1 2014: EUR 14.9 million). General and administrative expenses increased to EUR 7.0 million (H1 2014: EUR 6.7 million) driven by higher expenses for personnel.

Earnings before interest and taxes (EBIT) amounted to EUR 46.1 million (H1 2014: EUR 0.4 million). The Proprietary Development segment reported a segment EBIT of EUR 40.2 million (H1 2014: EUR -5.9 million), while Partnered Discovery showed a segment EBIT of EUR 12.5 million (H1 2014: EUR 12.5 million).

For the first half of 2015, MorphoSys realized a net profit of EUR 36.5 million compared to EUR 0.6 million in the same period of the previous year. The resulting diluted earnings per share for the six months ending 30 June 2015 amounted to EUR 1.39 (H1 2014: EUR 0.02).

On 30 June 2015, the Company held liquid funds and marketable securities, as well as other financial assets (reported in the balance sheet under cash and cash equivalents, available for sale financial assets, bonds available for sale and financial assets classified as loans and receivables), in the amount of EUR 324.9 million, compared to EUR 352.8 million on 31 December 2014. The net cash inflow from operations in H1 2015 was EUR 1.1 million (H1 2014: net cash outflow of EUR 9.9 million). The number of shares issued at 30 June 2015 was 26,469,834, compared to 26,456,834 on 31 December 2014.

Second Quarter of 2015 (IFRS)

In the second quarter of 2015, the Company generated revenues in the amount of EUR 12.2 million, compared to EUR 14.7 million in the same quarter of 2014. Total operating expenses amounted to EUR 23.2 million in Q2 2015, compared to EUR 15.6 million in the same quarter of 2014. EBIT amounted to EUR -6.7 million (Q2 2014: EUR -1.0 million). Net loss for the second quarter 2015 was EUR 4.3 million, compared to a net loss of EUR 0.5 million in the second quarter of 2014.

Outlook for 2015

MorphoSys re-confirmed its guidance for 2015. MorphoSys anticipates total Group revenues of EUR 101 million to EUR 106 million and anticipates a positive EBIT in the range of EUR 9 to EUR 16 million in 2015. Expenses for proprietary product and technology development are expected to amount to EUR 56 million to EUR 63 million.

On July 24, 2015 The U.S. Food and Drug Administration reported it approved Odomzo (sonidegib) to treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy (Press release, , JUL 24, 2015, View Source [SID:1234506626]).

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Skin cancer is the most common cancer and basal cell carcinoma accounts for approximately 80 percent of non-melanoma skin cancers. Basal cell carcinoma starts in the top layer of the skin (called the epidermis) and usually develops in areas that have been regularly exposed to the sun and other forms of ultraviolet radiation. According to the National Cancer Institute, the number of new cases of non-melanoma skin cancer appears to be increasing every year. Locally advanced basal cell skin cancer refers to basal cancers that have not spread to other parts of the body, but cannot be curatively treated with local treatments, specifically surgery and radiation.

Odomzo is a pill taken once a day. It works by inhibiting a molecular pathway, called the Hedgehog pathway, which is active in basal cell cancers. By suppressing this pathway, Odomzo may stop or reduce the growth of cancerous lesions.

"Our increasing understanding of molecular pathways involved in cancer has led to approvals of many oncology drugs in difficult-to-treat diseases for which few therapeutic options previously existed," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. "Thanks to a better understanding of the Hedgehog pathway, the FDA has now approved two drugs for the treatment of basal cell carcinoma just in the last three years." In 2012, Erivedge (vismodegib) was the first drug approved to treat locally advanced and metastatic basal cell carcinoma.

Odomzo carries a Boxed Warning alerting healthcare professionals that Odomzo may cause death or severe birth defects in a developing fetus when administered to a pregnant woman. Pregnancy status should be verified prior to the start of Odomzo treatment, and both male and female patients should be warned about these risks and advised to use effective contraception.

The efficacy of Odomzo was established in a multi-center, double-blind clinical trial, in which 66 patients with locally advanced basal cell carcinoma were randomly assigned to receive Odomzo 200 mg daily and 128 patients were assigned to receive Odomzo 800 mg daily. The study’s primary endpoint was objective response rate, which is the percentage of patients who experienced partial shrinkage or complete disappearance of their tumor(s). Results showed that 58 percent of patients treated with Odomzo 200 mg had their tumors shrink or disappear. This effect lasted at least 1.9 to 18.6 months, and approximately half of the responding patients’ tumor shrinkage lasted six months or longer. Response rates were similar in patients who received Odomzo 800 mg daily, however side effects were more common at this dose.

At a dose of 200 mg daily, the most common side effects of Odomzo were muscle spasms, alopecia (hair loss), dysgeusia (distortion in the sense of taste), fatigue, nausea, musculoskeletal pain, diarrhea, decreased weight, decreased appetite, myalgia (muscle pain), abdominal pain, headache, pain, vomiting and pruritus (itching). Odomzo also has the potential to cause serious musculoskeletal-related side effects, including increased serum creatine kinase levels [with rare reports of muscle tissue breakdown (rhabdomyolysis)], muscle spasms, and myalgia.

Odomzo is marketed by East Hanover, New Jersey-based Novartis Pharmaceuticals Corporation. Erivedge is marketed by Genentech in San Francisco, California.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

On July 24, 2015 CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, reported the closing of its previously announced underwritten public offering (Press release, CytRx, JUL 24, 2015, View Source;p=RssLanding&cat=news&id=2070943 [SID:1234506623]). The gross proceeds from its sale of 10,465,000 shares of common stock at a public offering price of $2.75 per share, including 1,365,000 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares, were approximately $28.8 million prior to deducting underwriting discounts and commissions and offering expenses payable by CytRx.

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CytRx intends to use the net proceeds of the offering to fund clinical trials of its drug candidate aldoxorubicin and its drug discovery activities and for general corporate purposes, which may include pre-commercialization activities relating to aldoxorubicin, working capital, capital expenditures, research and development and other commercial expenditures.

Jefferies LLC acted as the sole book-running manager for the offering. Oppenheimer & Co. Inc., Aegis Capital Corp., FBR Capital Markets & Co., and H.C. Wainwright & Co. acted as co-lead managers for the offering.

The shares described above were sold pursuant to a shelf registration statement on Form S-3, including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission (SEC). The final prospectus supplement related to the offering also has been filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus may be obtained from Jefferies LLC, Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by email at [email protected] or by phone at 877-547-6340 or by accessing the SEC’s website at View Source

On July 24, 2015 AbbVie (NYSE:ABBV) reported financial results for the second quarter ended June 30, 2015 (Press release, AbbVie, JUL 24, 2015, View Source;p=RssLanding&cat=news&id=2070868 [SID:1234506616]).

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"We are pleased with the high level of performance we’ve delivered through the first-half of 2015, consistent with our commitment to shareholders for top-tier growth this year and beyond," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "With the completion of the Pharmacyclics transaction, continued momentum from our on-market products and rapid evolution of our robust development pipeline, we are well positioned to deliver strong performance in the future."

Second-Quarter Results

Worldwide sales were $5.475 billion in the second quarter, up 11.1 percent year-over-year. On an operational basis, sales increased 19.4 percent, excluding an 8.3 percent unfavorable impact from foreign exchange rate fluctuations.

Second-quarter sales growth was driven by the continued strength of HUMIRA and other promoted products. Global HUMIRA sales increased 16.4 percent on an operational basis, or 7.6 percent including the impact of foreign exchange rate fluctuations. Strong U.S. HUMIRA growth continued, driven by double-digit growth across all three major market categories, rheumatology, dermatology and gastroenterology. Reported international HUMIRA sales growth in the quarter was reduced by nearly 18 percent due to unfavorable foreign exchange. First-half 2015 international HUMIRA sales grew nearly 9 percent on an operational basis, consistent with planning expectations and the full year forecast for international HUMIRA sales growth of 9 to 10 percent on an operational basis. As noted last quarter, the first-quarter international operational growth rate of nearly 15 percent was favorably impacted by the timing of shipments in select markets. Consequently, sales growth in the second quarter was negatively impacted by shipment timing.

Total company sales growth was also driven by $385 million in global VIEKIRA sales, now approved in 47 countries with additional approvals anticipated throughout the remainder of 2015, as well as strong operational growth from other key products including Creon, Synthroid and Duodopa.

Second-quarter U.S. IMBRUVICA sales were $234 million. AbbVie recorded a partial quarter of U.S. IMBRUVICA sales of $97 million and $10 million of international profit sharing based on the May 26 close date of the Pharmacyclics acquisition.

The adjusted gross margin ratio in the second quarter was 85.3 percent, excluding intangible asset amortization and other specified items. Gross margin expansion was driven by product mix, operating efficiencies and the impact of foreign exchange rates. The gross margin ratio under U.S. generally accepted accounting principles (GAAP) was 83.3 percent.

Adjusted selling, general and administrative (SG&A) expense was 25.1 percent of sales in the second quarter. On a GAAP basis, SG&A was 31.1 percent of sales.

Adjusted research and development (R&D) was 15.9 percent of sales in the quarter, reflecting funding actions in support of our mid- and late-stage pipeline assets. On a GAAP basis, R&D was 17.9 percent of sales.

The adjusted operating margin in the second quarter was 44.2 percent, compared to 36.4 percent in second-quarter 2014. On a GAAP basis, the operating margin was 33.8 percent.

Adjusted net interest expense was $137 million, which reflects the impact of debt issued in conjunction with the Pharmacyclics acquisition. The adjusted tax rate was 21.9 percent in the quarter and 18.6 percent on a GAAP basis.

Adjusted diluted earnings per share, excluding intangible asset amortization expense and other specified items, were $1.08 in the second quarter, up 31.7 percent. Diluted earnings per share were $0.83 on a GAAP basis.

Key Events from the Second Quarter

On May 26, AbbVie successfully completed the acquisition of Pharmacyclics, accelerating AbbVie’s clinical and commercial presence in oncology. The acquisition aligns strategically to AbbVie’s business model, strengthening the company’s already robust oncology pipeline and further diversifying AbbVie’s revenue base.

AbbVie announced that the European Commission granted marketing authorization for IMBRUVICA (ibrutinib) as the first treatment option specifically approved for treatment of adult patients with Waldenstrom’s macroglobulinemia.

Results from the Phase 3 HELIOS study of IMBRUVICA were presented at The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting. The data demonstrated that patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) experienced an 80 percent reduction in the risk of disease progression or death when treated with ibrutinib in combination with bendamustine and rituximab, compared to patients receiving placebo in combination with bendamustine and rituximab.

AbbVie reported top-line results from the head-to-head Phase 3, RESONATE-2 study, which evaluated efficacy and safety of ibrutinib versus traditional chemotherapy, chlorambucil. Initial findings showed that treatment with ibrutinib improved progression-free survival rates, as well as met several secondary endpoints, including overall survival and overall response rates when used in treatment-naïve patients with CLL and SLL. Additional detailed data will be presented at an upcoming medical meeting. AbbVie anticipates submitting these data for regulatory review in the second-half of 2015.

AbbVie announced its investigational medicine venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of CLL in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation. The 17p deletion mutation is a genomic alteration in which a part of chromosome 17 is absent. The median life expectancy for CLL patients with 17p deletion is less than 2-3 years. AbbVie expects to submit regulatory applications to U.S. and European agencies for this indication before the end of 2015.

Data from the Phase 3 ELOQUENT-2 study of elotuzumab were recently published in the New England Journal of Medicine. Elotuzumab is being developed in partnership with Bristol Myers Squibb, for front-line and relapsed/refractory multiple myeloma. Data showed that adding elotuzumab to standard of care in patients with relapsed/refractory multiple myeloma significantly reduced the risk of disease progression and demonstrated superior progression-free survival and overall response rates. The regulatory submissions are anticipated in the second-half of 2015.

The FDA granted priority review to AbbVie for its investigational, all-oral, interferon-free (IFN) therapy for the treatment of genotype 4 (GT4) chronic HCV in the United States. The New Drug Application (NDA) was accepted by the agency and is based on results from the PEARL-I study, which demonstrated 100 percent sustained virologic response rate at 12 weeks post-treatment (SVR12) when used with ribavirin (RBV), with no discontinuations due to adverse events. This investigational therapy also previously received Breakthrough Therapy Designation, and AbbVie anticipates regulatory action in the second-half of 2015.
New, pivotal data from the GIFT-I study of AbbVie’s all-oral, IFN- and RBV-free, two direct-acting antiviral (DAA) treatment with ombitasvir/paritaprevir/ritonavir in genotype 1b (GT1b) chronic HCV infected Japanese patients with and without cirrhosis were presented at the Annual Meeting of the Japan Society of Hepatology. Patients were both treatment-naïve and treatment-experienced. Primary endpoints were achieved, demonstrating 95 percent SVR12 in a sub-group of treatment-naïve, non-cirrhotic, adult GT1b chronic HCV infected Japanese patients who were eligible for therapy with IFN and had a high viral load. In study results related to the secondary endpoint, GT1b HCV patients with compensated cirrhosis achieved 91 percent SVR12. AbbVie’s two-DAA combination is currently under regulatory review in Japan and a decision is expected in the second-half of 2015.
AbbVie reported results from the TURQUOISE-III study in treatment-naïve and treatment-experienced patients with GT1b chronic HCV with compensated liver cirrhosis. These data demonstrated 100 percent SVR12 rates when treated with VIEKIRA without RBV. No patients discontinued treatment due to adverse events. Over time, chronic HCV may lead to liver complications, including compensated cirrhosis, in about 10-20 percent of people infected.

AbbVie announced that the FDA granted VIEKIRA orphan drug designation for the investigational treatment of HCV infection in pediatric patients, 0 – 16 years of age. Orphan drug designations recognize the need for a treatment of a rare disease or condition. AbbVie will conduct an investigational clinical study to evaluate the efficacy and safety of VIEKIRA with or without RBV in pediatric patients with chronic HCV infection. VIEKIRA is currently not approved for this indication.

AbbVie announced that the FDA granted HUMIRA orphan drug designation for the investigational treatment of moderate-to-severe hidradenitis suppurativa (HS), a painful, chronic inflammatory skin disease. AbbVie’s supplemental Biologic License Application (sBLA) is currently under review with the agency. The European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently granted a positive opinion for this indication.

AbbVie recently received approval from the EMA for a new HUMIRA formulation, specifically designed to reduce injection pain and reduce injection volume.

AbbVie announced results from VISUAL‑I, a Phase 3 study investigating the efficacy and safety of HUMIRA in adult patients with uveitis. Results showed HUMIRA significantly lowered their risk of uncontrolled uveitis or vision loss. In May 2014, AbbVie received orphan drug designation from the FDA for the investigational treatment of certain forms of non‑infectious uveitis with HUMIRA. U.S. and EU regulatory submissions are expected in the second-half of 2015, following positive results from the second pivotal trial.
On June 18, the AbbVie board of directors declared a quarterly cash dividend of $0.51 per share, payable Aug. 14, 2015 to stockholders of record at the close of business on July 15, 2015. Since the company’s inception in 2013, AbbVie has increased its dividend by 28 percent.

Full-Year 2015 Outlook

AbbVie is confirming its adjusted diluted earnings-per-share guidance for the full-year 2015 of $4.10 to $4.30. The company’s 2015 adjusted diluted earnings-per-share guidance excludes $0.84 per share of intangible asset amortization expense, deal costs, integration, and other specified items, and includes $0.20 of dilution related to the Pharmacyclics acquisition. AbbVie’s diluted earnings-per-share guidance is $3.26 to $3.46 on a GAAP basis.