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Johnson & Johnson to Participate in Cowen 38th Annual Healthcare Conference

On February 20, 2018 Johnson & Johnson (NYSE: JNJ) reported that it will participate in the Cowen 38th Annual Healthcare Conference on Tuesday, Mar. 13, at The Boston Marriott Copley Place, Boston (Press release, Johnson & Johnson, FEB 20, 2018, View Source [SID1234524072]). Ashley McEvoy, Company Group Chairman, Consumer Medical Devices will represent the Company in a session scheduled at 10:00 a.m. (Eastern Time).

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This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.

A webcast and podcast replay will be available approximately two hours after the live webcast.

HALOZYME REPORTS FOURTH QUARTER AND FULL-YEAR 2017 RESULTS

On February 20, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today reported financial results and recent highlights for the fourth quarter and full-year ended December 31, 2017 (Press release, Halozyme, FEB 20, 2018, View Source [SID1234524069]).

"Building on a truly transformative year in 2017, we begin 2018 executing against a strong portfolio of new ENHANZE collaborations," said Dr. Helen Torley, president and chief executive officer. "With Janssen now studying Darzalex SC in four Phase 3 trials, Roche recently initiating a Phase 1 study with ENHANZE and multiple targets projected to enter the clinic in the coming quarters, we have good line of sight to our goal of having six targets in clinical development by year-end, doubling the number of targets in the clinic from 2017.

"In our oncology pillar, we continue to project achieving the target number of progression-free survival events in HALO-301 late in the fourth quarter of 2018. In addition, we are making good progress in our exploration of the pan-tumor potential of PEGPH20 and look forward to sharing response-rate data from our combination studies with Halaven and potentially with Keytruda in the second half of the year. We begin 2018 in a strong position with multiple value-generating opportunities ahead for patients, the company and for shareholders."

Fourth Quarter 2017 and Recent Highlights include:

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Janssen expanding its development program for the subcutaneous formulation of DARZALEX (daratumumab) with six planned and ongoing clinical studies. Halozyme’s ENHANZE technology has the potential to enable a 15-ml injection to be delivered in five minutes or less. The ongoing or planned trials in patients with Amyloidosis, Smoldering Myeloma and Multiple Myeloma include four Phase 3 studies, one Phase 2 study and one Phase 1 study.

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Roche initiating a Phase 1 study of an undisclosed target with Halozyme’s ENHANZE drug-delivery technology.

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Alexion announcing plans to initiate a Phase 1 trial in 2018 to study a next-generation subcutaneous formulation of ALXN1210 (ALXN1210 SC) with ENHANZE.

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Baxalta and Roche achieving commercial milestones for products using ENHANZE triggering $5 million and $7 million in respective milestone payments.

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Continued progress screening and enrolling patients in the HALO-301 study of PEGPH20 in combination with ABRAXANE (nab-paclitaxel) and gemcitabine in first-line metastatic pancreas cancer patients with high levels of tumor hyaluronan (HA-High). An interim analysis will be conducted for the first primary endpoint of progression-free survival when the target number of events has been reached, which the company continues to project will be in late Q4.

Fourth Quarter 2017 Financial Highlights

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Revenue for the fourth quarter was $189.6 million compared to $39 million for the fourth quarter of 2016. The year-over-year increase was driven by $101.4 million recognized upon the effective date of the BMS collaboration, a $15 million milestone payment from Janssen, a $40 million upfront payment from Alexion and growth in royalties from partner sales of Herceptin (trastuzumab) SC, MabThera (rituximab) SC and HYQVIA (Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase), offset by a decrease in research and development reimbursements. Revenue for the fourth quarter included $17.7 million in royalties, an increase of 24 percent from the prior-year period, $8.4 million in sales of bulk rHuPH20 primarily for use in manufacturing collaboration products and $4.2 million in HYLENEX recombinant (hyaluronidase human injection) product sales.
Revenue for the full year was $316.6 million, compared to $146.7 million in 2016.
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Research and development expenses for the fourth quarter were $41.4 million, compared to $41.3 million for the fourth quarter of 2016.
Research and development expenses for the full year were $150.6 million, compared to $150.8 million in 2016.
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Selling, general and administrative expenses for the fourth quarter were $14.8 million, compared to $12.2 million for the fourth quarter of 2016. The increase was primarily due to personnel expenses, including stock compensation, for the period.
Selling, general and administrative expenses for 2017 were $53.8 million, compared to $45.9 million in 2016.

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Net income for the fourth quarter was $123.9 million, or $0.85 per share, compared to net loss in the fourth quarter of 2016 of $27.4 million, or $0.21 per share.
Net income for the full year was $63 million, or $0.45 per share, compared to a net loss of $103 million in 2016, or $0.81 per share.
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Cash, cash equivalents and marketable securities were $469.2 million at December 31, 2017, compared to $316.9 million at September 30, 2017.

Financial Outlook for 2018

Halozyme reiterated its financial guidance of:

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Net revenue of $115 million to $125 million, including 25% to 30% royalty growth;
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Operating expenses of $230 million to $240 million;
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Operating cash burn of $75 million to $85 million; and
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Year-end cash balance of $305 million to $315 million.

Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for the fourth quarter of 2017 today, Tuesday, February 20 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme’s corporate website and a recording made available following the close of the call. To access the webcast and additional documents related to the call, please visit halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The call may also be accessed by dialing (877) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 769890. A telephone replay will be available after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 95494046.

Lilly to Participate in Cowen Health Care Conference

On February 20, 2018 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the Cowen and Company 38th Annual Health Care Conference on Tuesday, March 13, 2018 (Press release, Eli Lilly, FEB 20, 2018, View Source [SID1234524067]). Sue Mahony, Ph.D., senior vice president and president of Lilly Oncology and Levi Garraway, M.D., Ph.D., senior vice president of global development and medical affairs for Lilly Oncology will participate in a fireside chat at 8:00 a.m., Eastern Time.

A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

BioCryst to Announce Fourth Quarter and Full Year 2017 Financial Results on February 27

On February 20, 2018 BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) reported that its fourth quarter and full year 2017 financial results will be reported on Tuesday, February 27, 2018 (Press release, BioCryst Pharmaceuticalsa, FEB 20, 2018, View Source [SID1234524065]).

BioCryst will host a conference call and webcast at 11:00 a.m. Eastern Time to discuss financial results and to provide an update regarding the Company’s clinical development programs. The call will be led by Jon P. Stonehouse, President & Chief Executive Officer, Thomas R. Staab II, Senior Vice President & Chief Financial Officer, and Dr. Bill Sheridan, Senior Vice President and Chief Medical Officer.

Links to a live audio webcast and replay of the presentation may be accessed on the BioCryst website events page at View Source

Athenex Announces Phase II Clinical Study Results for KX2-391 Ointment for the Treatment of Actinic Keratosis in the American Academy of Dermatology Meeting

On February 20, 2018 Athenex (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the Phase II clinical study data for KX2-391 for the treatment of actinic keratosis was presented by Dr. Seth Forman of Forward Clinical Trials, Tampa, at the American Academy of Dermatology Annual Meeting on February 17, 2018 in San Diego, California (abstract ID 6134) (Press release, Athenex, FEB 20, 2018, View Source;p=RssLanding&cat=news&id=2333323 [SID1234524063]).

Actinic keratosis is a common skin condition that is induced through ultra-violet light damage, resulting in patches of thick, scaly or crusty skin. Left untreated, the lesions have risk of progression to squamous cell carcinoma and consequently treatment by a dermatologist is recommended. Actinic keratosis is the most common pre-cancerous condition in dermatology and affects more than 55 million Americans. Actinic keratosis constitutes between 14-29% of dermatologist visits in the USA1.

KX2-391, also known as KX-01, is a first-in-class dual Src kinase and tubulin polymerization inhibitor being developed as a topical medicinal product for the treatment of actinic keratosis.

This Phase II clinical study aims to determine the activity, safety and pharmacokinetics of KX2-391 ointment 1% (5 days or 3 days) in adults with actinic keratosis on the face or scalp. This is an open-label, multicenter study conducted in adults who had 4-8 actinic keratosis lesions within a 25 cm2 area on the face or scalp. A cohort of subjects was given once daily application for 5 days and was assessed through Day 57 for actinic keratosis lesion counts, local skin reactions (LSRs), and adverse events (AEs). LSRs were scored on a scale of 0 to 4 (worst). A second cohort of 3-day treatment was enrolled after the 5-day treatment regimen demonstrated activity and safety.

A total of 168 patients were recruited (84 for each cohort) from 16 US clinical sites. Subjects were mostly white males, with a mean age of 68 years, skin type I to III and median baseline number of actinic keratosis lesions of 6 for the 5-day treatment cohort and 5 for the 3-day treatment cohort. The 5-day treatment cohort achieved a higher overall 100 percent clearance of actinic keratosis lesions at Day-57 (i.e. 8 weeks after the initiation of treatment) than the 3-day treatment cohort (43% vs. 32%). In the 5-day treatment cohort, 23 of 44 subjects (52%) with actinic keratosis on face and 13 of 40 (33%) on scalp attained 100 percent clearance at Day-57. LSRs were mild and mostly erythema, flaking/scaling, crusting and swelling with the majority of the LSRs scores of <2 and resolved rapidly. Only one subject scored 4 in erythema and flaking/scaling, which both resolved rapidly without concomitant medications. Erosions/ulcers and vesicles/pustules were observed in only 15% and 5% of subjects, respectively. No subjects scored ≥3 in erosions/ulcers/vesicles/pustules. Treatment related AEs were few and predominately mild transient application site pruritus, tenderness and pain. There were no treatment related serious AEs or discontinuations. Plasma levels of KX2-391 were low to undetectable.

Dr. Seth Forman, the presenting investigator for the Phase II study, commented, "This study demonstrated that KX2-391 ointment 1% is well tolerated and active as a field treatment of actinic keratosis of the face and the scalp with LSRs that are mostly mild and transient. KX2-391 ointment 1% daily for 5 consecutive days is currently being investigated in two Phase III placebo-controlled trials."

Dr. Rudolf Kwan, Athenex’s Chief Medical Officer, commented, "We are excited to see the excellent efficacy and safety profile of KX2-391 ointment 1% for the treatment of actinic keratosis. KX01 treatment may have the potential to change the paradigm of topical therapy for actinic keratosis."

Athenex and the FDA previously had an end of Phase II meeting regarding the program for the design of the Phase III studies. Two placebo-controlled Phase III studies, with a total target of 600 patients (300 patients for each study) were initiated on September 25, 2017 and the enrollment was completed rapidly ahead of an aggressive schedule. Athenex expects topline data of the Phase III studies to be available in the third quarter of 2018.

As previously announced on December 11, 2017, Athenex and Almirall, a leading skin-health focused global pharmaceutical company and one of the leaders in the field of actinic keratosis treatment, entered into a license agreement in which Athenex granted Almirall an exclusive license under the Athenex Intellectual Property to research, develop and commercialize KX2-391 in the United States of America and European countries, including Russia. Athenex will receive an upfront fee and near-term payments of up to USD $55 million, and additional indications milestones payment and a royalty payment starting at 15% based on annual net sales, with incremental increases in royalty rates with increased sales. Athenex retains certain co-promotion rights in the USA and retains the rights for other parts of the world including Canada, Central and South America, Japan, Asia and China, Australia and New Zealand, and Africa including South Africa. Almirall will employ its expertise to support the development in Europe and also to commercialize the product in the defined territories. Milestones were established to encourage the joint effort of Athenex and Almirall to develop additional indications and additional formulations.

Mr. Peter Guenter, Chief Executive Officer of Almirall, stated, "As one of the leaders of the medical treatment of actinic keratosis, we were excited by the potential profile of KX2-391, as demonstrated in this Phase II clinical study. We are also impressed by the Athenex team’s capabilities in drug development execution. We are pleased that the Athenex team has already completed the enrollment of the two Phase III studies of 600 patients in the USA. We are fully committed to this collaboration and will assist in the European development and registration strategy. We believe that KX2-391 has the potential to change the standard of care for actinic keratosis and look forward to combining our leadership abilities in the field with the drug development expertise of Athenex."

References

E. Stockfleth et al. Physician perceptions and experience of current treatment in actinic keratosis. JEADV 2015, 29, 298–306