On August 6, 2019 Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) reported financial results for the quarter and six months ended June 30, 2019, and provided updates on its development programs (Press release, Conatus Pharmaceuticals, AUG 6, 2019, View Source [SID1234538254]).

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Program Updates
During the second quarter, Conatus announced that top-line results from the company’s ENCORE-LF clinical trial of emricasan did not meet its primary endpoint, results from the 24-week extension in the company’s ENCORE-PH clinical trial of emricasan did not meet predefined objectives, and the company is discontinuing further treatment of patients enrolled in the ENCORE-LF trial. Consequently, Conatus and its partner, Novartis, have no further development plans for emricasan. Conatus plans to complete its ongoing clinical trials of emricasan for which the company is responsible under the collaboration agreement and is in discussions with Novartis for the wind-down of the collaboration.

In June 2019, Conatus announced that the company was implementing a restructuring plan in order to extend its resources, which included reducing staff and suspending development of its inflammasome disease candidate, CTS-2090. The company also announced that it had engaged Oppenheimer & Co., Inc., as its financial advisor to assist in the exploration and evaluation of strategic alternatives to enhance shareholder value. There can be no assurance of a successful outcome from these efforts, or of the form or timing of any such outcome.

Financial Results
The net loss for the second quarter of 2019 was $0.7 million compared with $4.5 million for the second quarter of 2018. The net loss for the first six months of 2019 was $5.4 million compared with $9.5 million for the first six months of 2018.

Total revenues consisted of collaboration revenue related to the company’s collaboration with Novartis. Total revenues were $10.8 million for the second quarter of 2019 compared with $8.8 million for the second quarter of 2018. The increase of $2.0 million was primarily due to a net cumulative catch-up in revenue recognized under the Novartis agreement, partially offset by lower revenues under the Novartis agreement due to lower emricasan-related research and development expenses.

Total revenues were $17.8 million for the first six months of 2019 compared with $18.5 million for the first six months of 2018. The decrease of $0.7 million was primarily due to lower revenues under the Novartis agreement due to lower emricasan-related research and development expenses, partially offset by a net cumulative catch-up in revenue recognized under the Novartis agreement.

Research and development expenses were $8.6 million for the second quarter of 2019 compared with $10.7 million for the second quarter of 2018. Research and development expenses were $17.9 million for the first six months of 2019 compared with $22.8 million for the first six months of 2018. These decreases were primarily due to lower emricasan-related research and development expenses and lower personnel costs, partially offset by recognition of severance and noncash stock compensation costs for research and development employees related to the restructuring plan announced in June 2019.

General and administrative expenses were $3.1 million for the second quarter of 2019 compared with $2.6 million for the second quarter of 2018. General and administrative expenses were $5.6 million for the first six months of 2019 compared with $5.3 million for the first six months of 2018. These increases were primarily due to recognition of severance and noncash stock compensation costs for general and administrative employees related to the restructuring plan announced in June 2019.

Cash, cash equivalents and marketable securities were $28.7 million at June 30, 2019, compared with $40.7 million at December 31, 2018. The company is projecting a year-end 2019 net balance of cash, cash equivalents and marketable securities of between $10 million and $15 million.

On August 6, 2019 Alder BioPharmaceuticals, Inc. (NASDAQ: ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, reported its financial results for the second quarter ended June 30, 2019 (Press release, Alder Biopharmaceuticals, AUG 6, 2019, View Source [SID1234538253]).

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"We continue to make significant progress toward the potential launch of eptinezumab in the U.S. in the first quarter of 2020. We have our commercial leadership team in place, with experienced personnel leading sales, marketing and market access. The team is sharpening our go-to-market strategy and expects to complete our commercial footprint later this year. We recently presented additional data further confirming eptinezumab’s differentiated clinical profile and benefits in patient-reported outcomes at the 2019 American Headache Society and American Academy of Neurology Annual Meetings," said Bob Azelby, Alder’s president and chief executive officer. "Looking forward, we believe there is a large opportunity to build value at Alder in the latter half of the year, with the initiation of eptinezumab’s acute study and the advancement of our product candidate, ALD1910, into the clinic. These collective activities align with our mission to forever change the migraine treatment landscape and give people with migraines their lives back."

Second Quarter 2019 Highlights and Recent Developments

Commercial readiness activities ongoing under the leadership of recently appointed chief commercial officer, Nadia Dac: As Alder prepares for the potential commercial launch of eptinezumab in the U.S. in the first quarter of 2020, the company has conducted new market research that further confirms eptinezumab’s differentiated profile and is prepared to begin account-level engagement with payers. The company plans to focus its marketing efforts on the high-prescribing headache specialist population and accounts, where eptinezumab fits well into their treatment protocols of quarterly patient visits with its short, 30-minute IV administration and its well-tolerated safety profile, as demonstrated in the company’s clinical trials. The company plans to utilize a specialty sales organization sized between 75 and 100 sales representatives.

New migraine-free months, migraine severity and quality of life data presented at AHS Annual Meeting: In July 2019, Alder presented new data from post-hoc analyses from its PROMISE 1 and PROMISE 2 Phase 3 clinical trials for eptinezumab at the American Headache Society’s (AHS) 61st Annual Scientific Meeting in Philadelphia, PA from July 11-14, 2019. Key highlights from the new data presented show 18.1% of episodic migraine patients treated with 100 mg of eptinezumab experienced no migraine days for at least half of the study period (≥six months), compared with 12.6% of placebo-treated patients, and 14.0% of chronic migraine patients treated with 100 mg of eptinezumab experienced no migraine days for at least half of the study period (≥three months), compared with 4.9% of placebo-treated patients. Data presented from PROMISE 2 also showed consistent clinically significant improvements in migraine severity in chronic migraine patients, a large contributor to impact on quality of life, starting at Month 1. Eptinezumab treatment resulted in clinically meaningful improvements in Headache Impact Test (HIT-6) scores in chronic migraine patients as early as Month 1 after treatment, which were maintained or further improved throughout the six-month study period, compared to placebo, which did not achieve a clinically meaningful improvement until Month 6. In addition, eptinezumab treatment resulted in clinically meaningful improvements greater than placebo in the 36-item Short-Form Health Survey (SF-36) scores in chronic migraine patients as early as Month 1 after treatment and through the six-month study period. From a safety perspective, longer-term exposure has demonstrated no change in the overall safety profile for eptinezumab.

Data showing consistency of rapid onset of migraine prevention and improvements in most bothersome migraine symptoms and patient reported outcomes data presented at AAN Annual Meeting: In May 2019, Alder presented efficacy data highlighting the consistency of the rapid onset of migraine prevention across four clinical trials with eptinezumab at the 71st American Academy of Neurology (AAN) Annual Meeting in Philadelphia, PA from May 4-10, 2019. Across the Phase 2 and Phase 3 clinical trials, it was observed that eptinezumab, with its 100% bioavailability at the end of infusion, showed a rapid onset of migraine prevention. The rapid response observed on both Day 1 and through Month 1 in PROMISE 1 and PROMISE 2 was also sustained through the first quarter following a single eptinezumab infusion, and was maintained or further increased through subsequent infusions. Alder also presented a new analysis of patient-reported outcomes data from the PROMISE 2 Phase 3 clinical trial of eptinezumab for the prevention of chronic migraine, showing improvements in the most bothersome migraine symptoms and patients’ global impression of change in their migraine status by Month 1 after treatment, with improvements sustained in overall response through the first and second quarterly infusions.

Upcoming Anticipated Milestones

Eptinezumab PDUFA target action date set for early 2020: The U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) filing for eptinezumab in April 2019, and set a Prescription Drug User Fee Act (PDUFA) target action date of February 21, 2020. If approved, eptinezumab will be the first-to-market IV therapy for migraine prevention, providing rapid and sustained prevention that begins on Day 1.

Acute study for eptinezumab to begin in 2H 2019: Alder plans to initiate a Phase 3 clinical trial evaluating eptinezumab as a treatment for acute migraine in patients who are candidates for prevention therapy in the second half of 2019. The trial will seek to leverage eptinezumab’s 100% bioavailability and rapid onset of prevention demonstrated in clinical testing, with the objective of securing an indication for the acute treatment of migraine for patients and positioning eptinezumab as the first anti-CGRP monoclonal antibody for both the treatment and prevention of migraine, if approved for both these indications.

ALD1910 to enter clinical development in 2019: Alder continues to advance its preclinical candidate, ALD1910, a monoclonal antibody targeting PACAP (pituitary adenylate cyclase-activating peptide) for migraine prevention. ALD1910 is currently undergoing Investigational New Drug (IND)-enabling preclinical studies. Alder expects to initiate a first in-human clinical study by the end of 2019.

Second Quarter 2019 Financial Results

As of June 30, 2019, Alder had $440.7 million in cash, cash equivalents, investments and restricted cash, compared to $412.4 million as of December 31, 2018.

Research and development expenses for the second quarter ended June 30, 2019 totaled $34.1 million, compared to $52.8 million for the same period in 2018. The year-over-year decrease was primarily due to a decrease in process development costs and a decrease in clinical trial costs due to the completion of patient treatments for several of the company’s clinical trials.

General and administrative expenses for the second quarter ended June 30, 2019 totaled $21.6 million, compared to $11.9 million for the same period in 2018. The year-over-year increase reflects efforts to support commercial readiness activities for eptinezumab.

Net loss applicable to common stockholders for the second quarter ended June 30, 2019 totaled $59.9 million, or $0.72 per share, compared to net loss of $70.7 million, or $1.04 per share on a fully-diluted basis, for the same period in 2018.

Financial Outlook

Alder continues to expect that full-year 2019 net cash used in operating activities and purchases of property and equipment will be in the range of $285 to $315 million. The majority of the spend is focused on ensuring that Alder is prepared for the potential launch of eptinezumab in the first quarter of 2020, including advancing eptinezumab’s supply chain, building commercial inventory, continuing to build out Alder’s commercial footprint and other pre-launch market readiness activities.

Alder believes its available cash, cash equivalents, investments and restricted cash will be sufficient to meet its projected operating requirements through the anticipated launch of eptinezumab and into the latter part of 2020.

Conference Call and Webcast

Alder will host a conference call today at 5:00 p.m. ET to discuss these financial results and recent corporate highlights. The live call may be accessed by dialing (877) 430-4657 for domestic callers or (484) 756-4339 for international callers, and providing conference ID number 6561825. The webcast will be broadcast live and can be accessed from the Events & Presentations page in the Investors section of Alder’s website at www.alderbio.com. The webcast will be available for replay following the call for at least 30 days.

On August 6, 2019 Myovant Sciences (NYSE: MYOV), a clinical-stage healthcare company focused on developing and commercializing innovative therapies for women’s health and prostate cancer, reported recent corporate updates and reported financial results for the first fiscal quarter ended June 30, 2019 (Press release, Myovant Sciences, AUG 6, 2019, View Source [SID1234538252]).

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"Myovant Sciences recently announced positive top-line data for the LIBERTY 1 and LIBERTY 2 studies evaluating relugolix combination therapy in women with uterine fibroids, as well as the positive results from a separate bioequivalence study supporting a potential one pill, once-a-day dosing regimen of relugolix combination therapy," said Lynn Seely, M.D., President and Chief Executive Officer of Myovant Sciences. "These results confirm the potential of relugolix to offer a constellation of attributes in a single pill, taken once-a-day and we are now focused on preparing for the New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA), which we plan to file by the end of this calendar year. We also look forward to reporting data from our Phase 3 prostate cancer study later this calendar year and results from our two Phase 3 endometriosis studies in the first and second quarters of calendar year 2020."
First Fiscal Quarter 2019 and Recent Business Highlights
Relugolix Phase 3 Clinical Programs

On May 14, 2019, Myovant Sciences announced positive top-line results from the LIBERTY 1 Phase 3 study evaluating relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) once-a-day in women with uterine fibroids and heavy menstrual bleeding. The study met its primary endpoint with a p-value of <0.0001 and achieved six key secondary endpoints with a well-tolerated safety profile.

On July 23, 2019, Myovant Sciences announced positive top-line results from the LIBERTY 2 Phase 3 study evaluating relugolix combination therapy in women with uterine fibroids and heavy menstrual bleeding. This study also met its primary endpoint with a p-value of <0.0001 and achieved six key secondary endpoints with a well-tolerated safety profile.

On July 23, 2019, Myovant Sciences also announced that the single-tablet relugolix combination therapy met all required FDA criteria in a separate bioequivalence study supporting a potential one-pill, once-a-day dosing regimen of relugolix.

Based on the positive top-line results for LIBERTY 1 and LIBERTY 2, Myovant Sciences currently plans to submit an NDA for one-pill, once-a-day relugolix combination therapy for the treatment of heavy menstrual bleeding and uterine fibroids to the FDA in the fourth quarter of calendar year 2019 and the Marketing Authorisation Application to the European Medicines Agency in the first quarter of calendar year 2020.

Enrollment of approximately 130 additional men with metastatic prostate cancer in the Phase 3 HERO study was completed in July 2019. The objective of enrolling these men was to assess the secondary objective of demonstrating that relugolix can delay the time to progression of the lethal state of the disease, castration-resistant prostate cancer, as compared to leuprolide.
MVT-602 Clinical Program

Myovant Sciences completed a successful dose-finding pharmacokinetic/pharmacodynamic Phase 2a study of MVT-602, a kisspeptin-1 receptor agonist, in healthy women undergoing a minimal controlled ovarian stimulation protocol. Top-line results were presented at the European Society of Human Reproduction in Vienna, Austria in June 2019. The study demonstrated that MVT-602 was generally well-tolerated and produced the desired luteinizing hormone surge associated with high and dose-dependent rates of ovulation in healthy women following a minimal controlled ovarian stimulation protocol.
Corporate

On June 4, 2019, Myovant Sciences completed an underwritten public equity offering, receiving net proceeds of approximately $134.5 million.

In the first quarter of fiscal year 2019, Myovant Sciences received aggregate net proceeds of $2.5 million pursuant to the issuance of common shares under its "at-the-market" equity offering program.
First Fiscal Quarter 2019 Financial Summary
Research and development (R&D) expenses for the quarter ended June 30, 2019, were $51.1 million compared to $51.3 million for the comparable prior year period. The composition of R&D expenses in both periods is similar, and primarily includes expenses related to Myovant Sciences’ Phase 3 clinical studies as well as personnel-related expenses for employees engaged in R&D activities. R&D expenses for the quarter ended June 30, 2018 reflected a ramp up in relugolix Phase 3 study costs primarily related to study enrollment, whereas R&D expenses for the quarter ended June 30, 2019 reflect lower relugolix Phase 3 study costs as certain studies are in the process of winding down. The decrease in relugolix Phase 3 study costs were partially offset by increases in other R&D spending related to Myovant Sciences’ preparations to seek regulatory approval for its product candidates.
General and administrative (G&A) expenses for the quarter ended June 30, 2019, were $14.2 million compared to $8.7 million for the comparable prior year period. The increase primarily reflects increases in personnel-related expenses, professional service fees, share-based compensation, and other general overhead and administrative expenses to support Myovant Sciences’ headcount growth and expanding operations.
Interest expense for the quarter ended June 30, 2019, was $3.8 million compared to $1.6 million in the comparable prior year period. The increase for the quarter was primarily the result of higher outstanding debt balances under the financing agreements as compared to the prior year period.
Interest income for the quarter ended June 30, 2019, was $0.8 million. There was no interest income for the quarter ended June 30, 2018. During the quarter ended June 30, 2019, a portion of Myovant Sciences’ cash was invested in a combination of money market funds and commercial paper. There were no such investments during the prior year period.

Net loss for the quarter ended June 30, 2019, was $67.9 million, compared to $62.1 million for the comparable prior year period. On a per common share basis, net loss was $0.89 and $0.98 for the quarters ended June 30, 2019, and 2018, respectively. The increase in the net loss for the quarter was driven primarily by the increase in costs outlined above.
Capital resources: Cash and cash equivalents totaled $226.7 million as of June 30, 2019. During the quarter ended June 30, 2019, Myovant Sciences raised net proceeds of approximately $134.5 million from an underwritten public equity offering and approximately $2.5 million from its "at-the-market" equity offering program. Myovant Sciences currently has approximately $10.4 million of capacity available under the "at-the-market" equity offering program that it initiated in April 2018.

About Relugolix
Relugolix is a once-a-day, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces ovarian estradiol and progesterone production, hormones known to stimulate uterine fibroids and endometriosis. Myovant Sciences has successfully completed two Phase 3 clinical studies (LIBERTY 1 and LIBERTY 2) evaluating relugolix combination therapy (relugolix 40 mg plus 1.0 mg estradiol with 0.5 mg norethindrone acetate) in women with heavy menstrual bleeding and uterine fibroids and is studying relugolix combination therapy in two Phase 3 clinical studies (SPIRIT 1 and SPIRIT 2) in women with endometriosis-associated pain. Data from SPIRIT 2 and SPIRIT 1 are expected in the first and second quarters, respectively, of calendar year 2020. Relugolix also lowers testosterone in men, an androgen known to drive the growth of prostate cancer. Myovant Sciences is evaluating relugolix, 120 mg once-a-day, in the Phase 3 HERO study in men with advanced prostate cancer. Top-line results from the HERO study are expected in the fourth quarter of calendar year 2019.

About MVT-602

MVT-602 is an oligopeptide kisspeptin-1 receptor agonist. Kisspeptin, the ligand, is a naturally-occurring peptide that stimulates GnRH release and is required for puberty and maintenance of normal reproductive function, including production of sperm, follicular maturation and ovulation, and production of estrogen and progesterone in women and testosterone in men. A Phase 2a clinical study in healthy female volunteers to characterize the dose-response curve in a minimal controlled ovarian stimulation setting has been completed.

On August 6, 2019 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics, reported financial results for the second quarter ended June 30, 2019 (Press release, Guardant Health, AUG 6, 2019, View Source [SID1234538251]).
Recent Highlights

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Total revenue for the second quarter of 2019 was $54.0 million, a 178% increase over the second quarter of 2018

Reported 11,875 tests to clinical customers and 5,285 tests to biopharmaceutical customers in the second quarter of 2019, representing increases of 77% and 112%, respectively, over the second quarter 2018

Results presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrated LUNAR RUO assay’s ability to identify early-stage colorectal cancer patients with post-operative molecular residual disease who may benefit from adjuvant therapy. Guardant remains on track to release a CLIA-validated version of the LUNAR assay for prospective clinical trials by the end of 2019

Announced plans to enroll first patient in ECLIPSE, a prospective colorectal screening study, by fourth quarter 2019

Completed an underwritten public offering raising $349.7 million in net proceeds
"During the quarter, the Guardant team made significant progress across multiple areas of our business in support of our mission to expand unprecedented access to cancer’s molecular information throughout all stages of the disease," said Helmy Eltoukhy, PhD, Chief Executive Officer. "We are especially encouraged by the strong adoption of Guardant360 and GuardantOMNI which we are seeing, even in the early phases of shifting the market to a blood-first paradigm for genomic testing."
Second Quarter 2019 Financial Results
Guardant Health adopted a new revenue recognition standard ("ASC 606") effective January 1, 2019, which primarily impacted the company’s recognition of revenue related to patient claims paid by third-party commercial and governmental payors. The company adopted ASC 606 using the modified retrospective method, which means that the total amount of revenue reported for the second quarter 2018 has not been restated in the current financial statements. Instead, the accumulated difference resulting from applying the new revenue standard to all contracts that were not completed as of adoption was recorded to accumulated deficit as of January 1, 2019.
Total revenue was $54.0 million for the three months ended June 30, 2019, a 178% increase from $19.4 million for the corresponding prior year period. Without the adoption of ASC 606, total revenue for the three months ended June 30, 2019 would have been $53.6 million, a 177% increase over the corresponding prior year period. Precision oncology revenue increased 136% driven by higher testing volume and increased revenue per test. There were 11,875 clinical tests and 5,285 biopharmaceutical tests performed during the second quarter of 2019. Development services revenue increased 664% primarily from new projects in 2019 related to companion diagnostic development and regulatory approval services for biopharmaceutical customers.
Gross profit, or total revenue less cost of precision oncology testing and cost of development services, was $37.1 million for the second quarter of 2019, an increase of $27.7 million from $9.4 million in the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 69% as compared to 49% in the corresponding prior year period.
Total operating expenses were $52.4 million for the second quarter of 2019, as compared to $32.1 million in the corresponding prior year period, an increase of 63%.
Net loss attributable to Guardant Health, Inc. common stockholders was $11.6 million in the second quarter of 2019 as compared to $21.6 million in the corresponding prior year period. Net loss per share attributable to Guardant Health, Inc. common stockholders was $0.13 in the second quarter of 2019, as compared to $1.75 in the corresponding prior year period.
Cash, cash equivalents and marketable securities were $822.9 million as of June 30, 2019.
2019 Financial Guidance
Guardant Health now expects full year 2019 total revenue to be in the range of $180 million to $190 million, representing 99% to 110% growth over the full year 2018. This compares to the company’s previous full year 2019 total revenue guidance of $145 to $150 million.

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Webcast and Conference Call Information
Guardant Health will host a conference call to discuss the second quarter 2019 financial results after market close on Tuesday, August 6, 2019 at 4:30 PM Eastern Time. The conference call can be accessed live over the phone (866) 417-5537 for U.S. callers or (409) 217-8233 for international callers (Conference ID: 3666557). The webcast can be accessed at View Source

On August 6, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported its financial results for the second quarter of 2019 (Press release, MorphoSys, AUG 6, 2019, View Source [SID1234538250]).

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"MorphoSys continued to make excellent progress on multiple fronts in the second quarter of 2019," said Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "A major step was the appointment of my successor Dr. Jean-Paul Kress as the new CEO of MorphoSys, effective September 1, 2019. Jean-Paul brings a wealth of medical, commercial and leadership expertise and I have every confidence that he will enable MorphoSys to make great strides in the execution of its strategy, especially in the launch and commercialization of our lead program tafasitamab. Topline results from the primary analysis of our L-MIND trial, followed by the presentation of the complete data set at the recent ICML conference, confirmed the potential of this program. We remain on track to completing our BLA filing to FDA by the end of this year and today we also confirmed our intention to submit a Marketing Authorization Application based on L-MIND to the European Medicines Agency. For the B-MIND trial, we have disclosed the biomarker we have implemented as a low baseline peripheral blood natural killer cell count, which may help us to identify patients who could benefit from tafasitamab’s potential efficient recruitment of these cells. Finally, our agreement with Vivoryon Therapeutics, which gives us access to a family of small molecule inhibitors in immuno-oncology, is a potentially invaluable addition to our proprietary portfolio. We are keen to assess the potential of these compounds in combination with our antibodies, first and foremost with tafasitamab", Dr. Moroney continued.

"The L-MIND data we have reported represent a key catalyst for the transformation of MorphoSys and our goal to develop into a fully integrated biopharmaceutical company. Our preparations to further broaden the development of tafasitamab are ongoing and the start of a first line trial in DLBCL is expected later this year. We are also broadening our development of MOR202, which we plan to test in a phase 1/2 clinical trial in a chronic inflammatory autoimmune disease of the kidneys later this year," commented Jens Holstein, Chief Financial Officer of MorphoSys AG. "Our balanced business model is based on the value of our Partnered Discovery segment that allows us to invest in the development and planned commercialization of our proprietary portfolio. The milestone payment of EUR22 million from GSK following the phase 3 start in rheumatoid arthritis with otilimab, formerly MOR103, led us to increase our financial guidance. An increasing royalty stream from Tremfya(R) further strengthens our cash position and we are confident that there will be other compounds that follow Tremfya’s(R) market entry in the future."

Financial Review for the second quarter of 2019 (IFRS; all figures rounded)

In Q2 2019 MorphoSys continued to focus on the research and development of drug candidates both for its own account as well as with its partners. Group revenues increased to EUR34.7 million in Q2 2019 as compared to EUR8.1 million in the second quarter of the previous year. The increase was mainly driven by the milestone payment of EUR22 million from GSK due to the start of the clinical phase 3 program with otilimab (MOR103) in rheumatoid arthritis (RA). This payment was recognized in the second quarter due to the provisions of IFRS 15 on revenues from variable consideration.

Revenues also included an estimate of royalties on net sales of Tremfya(R) amounting to EUR 7.1 million (estimate only since royalties for Q2 2019 had not been reported by Janssen as of the balance date).

In the Proprietary Development segment, MorphoSys focuses on research into, and clinical development of, its own drug candidates in the fields of cancer and inflammation. In Q2 2019, this segment recorded revenues of EUR25.9 million (Q2 2018: EUR0.1 million). In the Partnered Discovery segment, MorphoSys applies its proprietary technology to discover new drug candidates for pharmaceutical companies, benefiting from its partners’ development advancements through R&D funding, licensing fees, success-based milestone payments and royalties. In Q2 2019, revenues in this segment amounted to EUR8.7 million (Q2 2018: EUR8.1 million).

Total operating expenses were EUR40.3 million in the second quarter of 2019 (Q2 2018:
EUR32.7 million). In Q2 2019, research and development expenses amounted to EUR24.7 million, as compared to EUR25.8 million in the second quarter of 2018. Expenses for proprietary R&D, including technology development, amounted to EUR22.5 million (Q2 2018: EUR23.7 million). In the second quarter of 2019, cost of sales amounted to EUR4.9 million (in Q2 2018, this item did not exist), selling expenses amounted to EUR3.2 million (Q2 2018: EUR1.5 million). General and administrative expenses increased from EUR5.5 million in Q2 2018 to EUR7.5 million in Q2 2019.

Earnings before interest and taxes (EBIT) in Q2 2019 was -EUR5.7 million (Q2 2018: -EUR24.1 million). The Proprietary Development segment reported an EBIT of -EUR7.0 million (Q2 2018:
-EUR24.6 million). EBIT in the Partnered Discovery segment was EUR6.3 million (Q2 2018: EUR5.5 million). In Q2 2019, the consolidated net result was -EUR5.9 million (Q2 2018:
-EUR23.5 million). The earnings per share for Q2 2019 was -EUR0.19 (Q2 2018: -EUR0.76).

At the end of Q2 2019, the Company had EUR409.2 million in cash, reported on the balance sheet under the line items "cash and cash equivalents"; "financial assets at fair value through profit or loss"; and current and non-current "other financial assets at amortized cost". On December 31, 2018, the Group’s liquidity position amounted to EUR454.7 million.

The number of shares issued totaled 31,839,572 at the end of Q2 2019 (year-end 2018: 31,839,572).

Results for the first six months 2019

During the first six months of 2019, group revenues increased to EUR48.2 million (Q1-Q2 2018: EUR10.9 million). Revenues in the first half of 2019 comprised the milestone payment by GSK of EUR22.0 million due to the start of phase 3 clinical development of otilimab in RA. Expenditure for proprietary R&D, including technology development, amounted to EUR45.1 million in the first six months of 2019 (Q1-Q2 2018: EUR39.2 million). Consequently the EBIT in the first six months of 2019 amounted to -EUR29.3 million, compared to -EUR43.2 million in the first half of 2018.

Financial Guidance and Operational Outlook for 2019

Following a milestone payment of EUR22 million made by GSK on July 3, 2019 that was triggered by the start of phase 3 clinical development of otilimab (MOR103), MorphoSys increased its financial guidance. For the year 2019, MorphoSys expects revenues in the range EUR65 to 72 million (up from previously EUR43 to 50 million), and EBIT of -EUR105 to -115 million (from previously -EUR127 to -137 million). Expenses for proprietary development and technology development are expected to remain in a corridor of EUR95 to 105 million.

The guidance does not include revenues from potential future partnership or licensing agreements for tafasitamab or any other compound currently in MorphoSys’s Proprietary Development segment. Effects from potential in-licensing or co-development deals for new development candidates are also not included.

In its Proprietary Development segment, MorphoSys expects the following events and activities until the end of 2019:

Tafasitamab (MOR208)

L-MIND trial
Submission of Biologics License Application to U.S. FDA by year-end
Presentation of headline data from virtual, lenalidomide-only control arm planned for year-end
B-MIND trial
Continue phase 3 study evaluating tafasitamab plus bendamustine in r/r DLBCL
Event-driven interim analysis expected to occur in Q4 2019
Front-line DLBCL: Initiate phase 1b trial of tafasitamab in combination with R-CHOP or R2-CHOP in Q4 2019
COSMOS: Continue phase 2 trial of tafasitamab in combination with idelalisib or venetoclax in r/r CLL/SLL, with data to be presented at a medical conference at the end of 2019
MOR202

MorphoSys: Start a clinical phase 1/2 trial of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN) in Q4 2019
I-Mab: Continue two clinical trials of MOR202/TJ202 in multiple myeloma in the Chinese region
MOR106

Continue phase 2 intravenous IGUANA study, phase 1 subcutaneous bridging study and the recently started phase 2 GECKO trial as well as prepare for a Japanese ethno-bridging study in atopic dermatitis together with Galapagos and under global licensing agreement with Novartis

In its Partnered Discovery segment, MorphoSys expects the following events until end of 2019:

According to information provided on clinicaltrials.gov, by the end of 2019 primary completion may be reached in up to eight clinical trials in phases 2 and 3 from partners evaluating antibodies made using MorphoSys’s technology. These include:

A potentially pivotal phase 2b study by Mereo BioPharma in osteogenesis imperfecta (brittle bone syndrome) of the HuCAL antibody setrusumab (BSP804) directed against sclerostin (this antibody was generated within the scope of MorphoSys’s partnership with Novartis and subsequently licensed from Novartis to Mereo),
Further phase 3 trials of Tremfya(R) conducted by Janssen in psoriatic arthritis and a potential submission of a BLA planned for later this year as communicated by Janssen.
Moreover, Janssen plans the start of a phase 1 trial of guselkumab in Chinese healthy volunteers, a phase 2 trial of guselkumab in pityriasis rubra pilaris, a phase 2/3 trial in ulcerative colitis and a phase 3 trial in palmoplantar-non-pustular psoriasis, according to clinicaltrials.gov.

Whether, when and to what extent news will be published following the primary completion of trials in the Partnered Discovery segment is at the full discretion of MorphoSys’s partners.

MorphoSys will continue to support its proprietary development activities by evaluating potential in-licensing, co-development, and/or acquisition opportunities or the potential initiation of new proprietary development programs with the goal of maintaining and expanding the Company’s position in its current therapeutic and technological fields of activities.

1) Including MOR107, which concluded a phase 1 study in 2017 and is currently in preclinical investigation with a focus on oncology indications. Tremfya(R) is still considered as a clinical program due to ongoing studies in various indications.

2) Including otilimab (MOR103/GSK3196165), which is fully out-licensed to GSK, and MOR106, for which MorphoSys and Galapagos have signed a global licensing agreement with Novartis.

PP – Percentage points

MorphoSys will hold its conference call and webcast tomorrow, August 7, 2019 to present the second quarter financial results 2019 and a further outlook for 2019.

Dial-in number for the analyst conference call (in English) at 2:00pm CEST; 1:00pm BST; 8:00am EDT:

Germany: +49 69 201 744 220
For UK residents: +44 203 009 2470
For US residents: +1 877 423 0830
Participant PIN: 43166710#

Please dial in 10 minutes before the beginning of the conference.

A live webcast and slides will be made available at View Source

Approximately two hours after the call, a slide-synchronized audio replay of the conference and a transcript will be available at View Source

The Half-Year Report 2019 (IFRS) is available online at
View Source