On November 6, 2018 Diplomat Pharmacy, Inc. (NYSE: DPLO), the nation’s largest independent provider of specialty pharmacy services, reported financial results for the quarter ended September 30, 2018 (Press release, Diplomat Speciality Pharmacy, NOV 6, 2018, View Source [SID1234530763]). All comparisons, unless otherwise noted, are to the quarter ended September 30, 2017. Prior period financials have been recast to include certain direct expenses as part of cost of sales instead of selling, general and administrative ("SG&A") expense for our specialty segment. This change is a reclassification only and has no impact on overall results.

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Third Quarter 2018 Highlights include:

Revenue of $1,373 million, compared to $1,125 million, an increase of 22%
Specialty segment revenue of $1,212 million, compared to $1,125 million
PBM segment revenue of $170 million, which was not part of the business in the prior year period
Specialty segment total prescriptions dispensed of 230,000, compared to 222,000
PBM segment total volume, adjusted to 30-day equivalent, of 1,931,000
Gross margin of 6.8% versus 5.8%
Specialty segment gross margin of 5.5% versus 5.8%
PBM segment gross margin of 15.5%
EPS of $0.00 per diluted common share versus $0.01
Adjusted EBITDA of $41.9 million, compared to $23.2 million
Adjusted EBITDA margin of 3.1% versus 2.1%
Net cash used in operating activities was $33.4 million, compared to net cash provided by operating activities of $38.3 million
Net Debt, including contingent consideration, increased to $646.7 million, from $609.2 million at June 30, 2018
Brian Griffin, Chairman and CEO of Diplomat, commented, "Third quarter results were solid as we continue to successfully execute on our growth plan. Results were driven by strong Specialty segment growth and PBM performance. We recently opened our new state-of-the-art distribution and call center facility in Chandler, Arizona, furthering our efforts to provide the highest quality patient care nationwide. Every day we put our patients first, while at the same time investing in initiatives to drive further growth and productivity."

Third Quarter Financial Summary:

Revenue for the third quarter of 2018 was $1,373 million, compared to $1,125 million in the third quarter of 2017, an increase of $248 million or 22%. Revenue was comprised of $1,212 million and $170 million from our Specialty segment and our Pharmacy Benefit Management ("PBM") segment, respectively. The increase in our Specialty segment was driven by manufacturer price increases, approximately $10 million from our recent acquisitions, access to dispense drugs that were new in the past year and increased volume due to both payor and physician relationships. These increases were partially offset by a decrease in hepatitis C business versus the prior year period and reimbursement compression.

Gross profit in the third quarter of 2018 was $93.4 million and generated a 6.8% gross margin, compared to $65.1 million gross profit and a 5.8% gross margin in the third quarter of 2017. Gross profit was comprised of $67.0 million and $26.3 million from our Specialty segment and PBM segment, respectively. The gross margin increase in the quarter was primarily due to the impact of our PBM acquisitions, partially offset by reimbursement compression in our Specialty segment.

SG&A expenses for the third quarter of 2018 were $83.4 million, an increase of $20.6 million, compared to $62.8 million in the third quarter of 2017. This increase is primarily driven by an $11.0 million increase in employee cost, including employee cost for our acquired entities and a $4.0 million increase in share-based compensation. Also contributing to the SG&A expense increase was a $7.0 million increase in amortization expense from definite-lived intangible assets, inclusive of capitalized software for internal use, associated with our acquired entities. We also experienced increases in other SG&A expenses; including, rent due to the addition of our Chandler, Arizona facility, travel, consulting and professional fees, as well as other miscellaneous expenses. These increases were partially offset by a $2.4 million decrease in acquisition related expenses.

Net income attributable to Diplomat for the third quarter of 2018 was $0.2 million compared to $1.0 million in the third quarter of 2017. This decrease was primarily driven by an $8.1 million increase in interest expense due to a significant increase in outstanding debt to fund our PBM acquisitions, partially offset by a $7.6 million increase in income from operations. Adjusted EBITDA for the third quarter of 2018 was $41.9 million compared to $23.2 million in the third quarter of 2017, an increase of $18.7 million.

Earnings per share for the third quarter of 2018 was $0.00 per basic/diluted common share, compared to $0.01 per basic/diluted common share for the third quarter of 2017.

2018 Financial Outlook

For the full-year 2018, we are updating our previous financial guidance:

Revenue between $5.5 and $5.7 billion, versus the previous range of $5.5 and $5.9 billion
Net (loss) income attributable to Diplomat between $(7.5) and $2.6 million, versus the previous range of $(11.0) and $0.5 million
Adjusted EBITDA between $164 and $170 million, no change to previous range
Diluted EPS between $(0.10) and $0.03, versus the previous range of $(0.15) and $0.01
Our EPS expectations assume approximately 74,300,000 weighted average common shares outstanding on a diluted basis and a tax rate of (10)% and 40% versus (5)% and 32%, for the low- and high-end of the range, respectively, for the full year 2018, each of which could differ materially.

Earnings Conference Call Information

As previously announced, the Company will hold a conference call to discuss its third quarter performance this evening, November 6, 2018, at 5:00 p.m. Eastern Time. Shareholders and interested participants may listen to a live broadcast of the conference call by dialing 833-286-5805 (647-689-4450 for international callers) and referencing participant code 7553049 approximately 15 minutes prior to the call. A live webcast of the conference call and associated slide presentation will be available on the investor relations section of the Company’s website for approximately 90 days at ir.diplomat.is.

On November 6, 2018 Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company pioneering the use of DARPin therapeutics* to treat serious diseases, reported that the company plans to participate in several upcoming scientific conferences in November and December 2018 (Press release, Molecular Partners, NOV 6, 2018, View Source [SID1234530786]). At these conferences listed below, members of the Molecular Partners team will present updated research and preclinical data on the company’s DARPin "toolbox" as well as on MP0310, its most advanced multi-specific (FAP x 4-1BB) DARPin immuno-oncology compound, and on FAP x CD40, a second multi-specific DARPin immuno-oncology compound.

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33th Annual Meeting of Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)
Washington D.C., November 9-10, 2018
Focus: (1) MP0310 (FAP x 4-1BB); (2) FAP x CD40 candidate
Titles: (1) Preclinical identification of the pharmacologically active dose range of the tumor-targeted
4-1BB agonist MP0310 based on tumor regression, receptor occupancy and CD8 T lymphocyte expansion;
(2) Fibroblast activation protein (FAP)-selective delivery of CD40 agonistic DARPin molecule for tumor-restricted immune activation
EORTC-NCI-AACR 2018
Dublin, November 14, 2018
Focus: FAP x CD40 candidate
Title: Bispecific CD40/FAP DARPin molecule for tumor-restricted immune activation
PEGS Europe
Lisbon, November 16, 2018
Focus: MP0310 (FAP x 4-1BB)
Title: Tumor-targeted DARPin drug candidates for tumor-restricted immune cell co-activation
4th Annual ICI Europe Summit
Berlin, November 29, 2018
Focus: FAP x CD40 candidate
Title: Fibroblast activation protein (FAP)-selective delivery of CD40 agonistic DARPin protein for tumor-localized immune activation
Tumor Models London Meeting
London, December 6, 2018
Focus: MP0310 (FAP x 4-1BB)
Title: Preclinical animal models for therapeutic clinical dose predictions and PD assessment
IBC Antibody Engineering & Therapeutics
San Diego, December 13, 2018
Focus: MP0310 (FAP x 4-1BB)
Title: Cancer therapy revisited
The corresponding posters and/or presentations will be available on the company’s webpage after they are presented. Please visit the scientific presentations section of Molecular Partners’ website.

Financial Calendar
November 1, 2018 – Q3 2018 Management Statement
December 6, 2018 – R&D Day in New York
February 7, 2019 – Publication of Full-year Results 2018 (unaudited)
March 15, 2019 – Expected Publication of Annual Report 2018
April 16, 2019 – Annual General Meeting
May 9, 2019 – Interim Management Statement Q1 2019
August 27, 2019 – Publication of Half-year Results 2019 (unaudited)
October 31, 2019 – Interim Management Statement Q3 2019
View Source

About the DARPin Difference
DARPin therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin candidates are potent, specific, safe and very versatile. They can engage more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics.
The DARPin technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin therapeutics have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin drug candidates in oncology and immuno-oncology. The most advanced global product candidate is abicipar, a molecule currently in phase 3, in partnership with Allergan. Several DARPin molecules for various ophthalmic indications are also in development. The most advanced DARPin therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of solid tumors and hematological tumors. MP0274, the second-most advanced DARPin drug candidate owned by Molecular Partners, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 is currently in phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin is a registered trademark owned by Molecular Partners AG.

On November 6, 2018 Idera Pharmaceuticals, Inc. (NASDAQ: IDRA), a clinical-stage biopharmaceutical company focused on the development, and ultimately the commercialization, of therapeutic drug candidates for both oncology and rare disease indications characterized by small, well-defined patient populations with serious unmet medical needs, reported its financial and operational results for the third quarter ended September 30, 2018 (Press release, Idera Pharmaceuticals, NOV 6, 2018, View Source [SID1234530826]).

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"The third quarter of 2018 was marked by continued focus and execution throughout our company advancing the tilsotolimod ILLUMINATE 301 trial toward approval in our lead indication in anti-PD-1 refractory or relapsed metastatic melanoma. We also made significant progress framing our plans to expand the development of tilsotolimod to additional tumor types," stated Vincent Milano, Idera’s Chief Executive Officer.

"Over these past several years, through all of the preclinical studies, translational data collections and ultimately our early clinical experiences, it’s becoming clearer to us that the potential utility of tilsotolimod is not limited to melanoma and is certainly not limited by the location or type of tumor," continued Milano. "We look forward to providing our next clinical update from the ILLUMINATE 204 trial in the first half of December as well as laying out our expansion plans for the program in the beginning of 2019."

"The majority of our company’s focus is and will remain towards maximizing the opportunity with, and more importantly, the number of patients that can benefit from, tilsotolimod. At the same time, we recognize and embrace the concept of continuing to build Idera for the future. To that end, we will continue to be aggressive in our pursuit of additional assets to further drive value for our shareholders, and more importantly, meet the needs of patients suffering from rare diseases with serious unmet needs."

Clinical Development Program Updates:

ILLUMINATE (tilsotolimod) Clinical Development

ILLUMINATE 301 — Randomized Phase 3 trial of intratumoral tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with PD-1 refractory/relapsed metastatic melanoma:

· Trial initiated in the first quarter of 2018;

· 42 of the planned up to 110 sites across 12 countries have been activated for the randomization of patients into the trial;

· ILLUMINATE 301 Trials in Progress (TiPS) presentation on trial design featured at the 2018 Congress of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper);

· Planned enrollment of approximately 300 patients with Overall Response Rate ("ORR") and Overall Survival as primary endpoints; and

· U.S. Food and Drug Administration granted Fast Track Designation in fourth quarter of 2017 for tilsotolimod in combination with ipilimumab for the treatment of patients with unresectable or metastatic melanoma following failure of PD-1 inhibitor treatment.

ILLUMINATE 204 — Phase 1/2 trial of intratumoral tilsotolimod in combination with either ipilimumab or pembrolizumab in patients with PD-1 refractory/relapsed metastatic melanoma:

Ipilimumab Combination Arm — Phase 2 Recruitment Ongoing

· Enrollment continues at 10 U.S. clinical trial sites;

· Two additional sites planned for initiation in November 2018;

· ILLUMINATE 204 Trial Data update presented at ESMO (Free ESMO Whitepaper) 2018 demonstrated both abscopal effect as well as the potential of intratumoral tilsotolimod to overcome known resistance mechanisms to ipilimumab treatment as a monotherapy.

· Earlier this year at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, the company presented clinical efficacy and safety data from the first 21 evaluable patients demonstrating:

· Confirmed RECIST v1.1 responses (including 2 Complete Responses [CR]) were observed in 8 of these 21 subjects (38.1%);

· Overall 15 patients out of 21 evaluable for efficacy (71.4%) experienced disease control (CR, PR, or SD);

· The combination regimen was generally well tolerated. 6/26 subjects (23%) had immune-related toxicities indicating that IMO-2125 + ipilimumab does not appear to add toxicity versus ipilimumab alone;

· Injection-related toxicities were grade 1-2 transient fever and flu-like symptoms lasting <48 hours;

· 15/26 patients (57.7%) with lesions accessible only by image-guided injection (5 deep visceral lesions and 10 lymph nodes) were included; and

· The company plans to provide a data update on up to 35 evaluable patients in first half of December 2018.

Pembrolizumab Combination Arm — Phase 1 Dose Escalation Ongoing

· Enrollment in the last dosing cohort (32 mg) ongoing with one patient remaining to complete enrollment (priority enrollment has been towards the ipilimumab combination arm of ILLUMINATE 204).

· One patient in the cohort testing 16mg intratumoral tilsotolimod in combination with pembrolizumab continues on study with a confirmed complete response (CR).

ILLUMINATE 101 — Phase 1b trial of intratumoral tilsotolimod monotherapy in patients with refractory solid tumors:

· Completed enrollment in all four dose ranging cohorts; 41 patients enrolled;

· Continuing enrollment into the refractory melanoma cohort at the 8 mg dose of intratumoral tilsotolimod as monotherapy;

· Translational data continues to be collected, analyzed and is planned to be submitted for presentation at a medical oncology conference in 2019.

Investigator Sponsored Trials (IST)

Idera is supportive of several Investigator Sponsored Trials and continues to evaluate additional proposals:

· A Phase 1/2 open label study of intratumoral tilsotolimod in combination with intratumoral ipilimumab and IV nivolumab in a protocol open to multiple tumor types including non-small cell lung cancer (NSCLC), melanoma, squamous cell carcinoma of the head and neck and urothelial carcinoma. The principal investigator initiating this trial is Aurélien Marabelle, MD, PhD, Clinical Director of the Cancer Immunotherapy Program at Institut Gustave Roussy, Villejuif, France; and

· A Phase 2 placebo-controlled study of intradermal administration of tilsotolimod in patients with T3/T4 primary melanoma scheduled to undergo a combined re-excision and sentinel node biopsy (SNB) procedure. The principal investigators initiating this trial are Bas Koster, MD and Tanja de Gruijl, PhD at The VU University Medical Center, Amsterdam, the Netherlands.

Corporate Updates:

During the quarter, the following Corporate Organizational Changes were announced:

· Howard Pien appointment to Idera’s Board of Directors on September 18, 2018, filling the seat previously held by Julian Baker.

· Bryant D. Lim joined Idera as General Counsel and Secretary to the Board of Directors, effective September 10, 2018;

· Chief Financial Officer Louis J. Arcudi III’s planned departure from the company related to the company’s consolidation to PA headquarters, effective October 31, 2018;

· Vice President of Finance John J. Kirby’s appointment as Principal Financial Officer and Principal Accounting Officer, effective October 31, 2018; and

Financial Results

Third Quarter Results

Net loss applicable to common stockholders for the three months ended September 30, 2018 was $11.6 million, or $0.43 per basic and diluted share, compared to net loss applicable to common stockholders of $14.5 million, or $0.78 per basic and diluted share, for the same period in 2017. Revenue in each of the three months ended September 30, 2018 and 2017 was nominal. Research and development expenses for the three months ended September 30, 2018 totaled $8.9 million compared to $10.9 million for the same period in 2017. General and administrative expense for the three months ended September 30, 2018 totaled $4.0 million compared to $3.9 million for the same period in 2017. Merger-related costs, net for the three months ended

September 30, 2018 amounted to a net credit of $3.8 million and was comprised of a $6.0 million fixed expense reimbursement received in connection with the termination of the company’s proposed merger with BioCryst Pharmaceuticals, Inc., which was terminated in July 2018; partially offset by $2.2 million of expenses incurred in connection with the transactions contemplated by the related merger agreement. No such costs were incurred during 2017. Restructuring costs for the three months ended September 30, 2018 totaled $3.0 million and are a result of our decision in July 2018 to wind-down our discovery operations, reduce the workforce in Cambridge, Massachusetts that supported such operations, and close our Cambridge facility. No such costs were incurred during 2017.

As of September 30, 2018, the company’s cash and cash equivalents totaled $82.5 million. The company currently anticipates that, based on its current operating plan, its existing cash and cash equivalents will be sufficient to fund company operations into the first quarter of 2020.

On November 6, 2018 Alkermes plc (Nasdaq: ALKS) reported that its corporate presentation will be webcast live at the Credit Suisse 27th Annual Healthcare Conference on Tuesday, Nov. 13, 2018 at 10:20 a.m. MT (12:20 p.m. ET/5:20 p.m. GMT) from Scottsdale, Arizona (Press release, Alkermes, NOV 6, 2018, View Source;p=RssLanding&cat=news&id=2375640 [SID1234530867]). In addition, Alkermes’ corporate presentation will be webcast live at the Jefferies London Healthcare Conference on Wednesday, Nov. 14, 2018 at 4:00 p.m. GMT (11:00 a.m. ET) from London, U.K. These presentations may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

On November 6, 2018 RXi Pharmaceuticals Corporation (NASDAQ: RXII) a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform reported that it will report its financial results for the third quarter ended September 30, 2018, and provide a business update on Wednesday, November 14, 2018 after the close of the U.S. financial markets (Press release, RXi Pharmaceuticals, NOV 6, 2018, View Source [SID1234530887]).

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A live audio webcast will begin at 4:30 p.m. EDT. The webcast link is available under the "Investors – Events and Presentations" section of the Company’s website, www.rxipharma.com. The event may also be accessed by dialing toll-free in the United States: +1 844-376-4678. International participants may access the event by dialing: +1 209-905-5958.

An archive of the webcast will be available on the Company’s website approximately two hours after the presentation.