Halozyme Therapeutics, Inc. (NASDAQ:HALO) Q3 2008 Earnings Call Transcript November 6, 2008 4:30 AM ET
Robert Uhl -- Senior Director, IR
Jonathan Lim – President and CEO
Gregory Frost – VP and Chief Scientific Officer
Robert Little – VP and Chief Commercial Officer
David Ramsay – VP and CFO
Kevin Jason [ph]
Lu Nan [ph]
Welcome to the Halozyme 2008 third quarter financial results and pipeline update conference call. At this time, all participants are in a listen only mode. Following management’s prepared remarks, we will hold a question and answer session. (Operator instructions). As a reminder, this conference call is being recorded today, November 6, 2008. I’ll now like to turn the call over to Mr. Robert Uhl, Senior Director of Investor Relations at Halozyme. Please go ahead.
Thank you, operator, and thanks also to everyone for participating in today’s call.
I am Robert Uhl, Senior Director of Investor Relations at Halozyme Therapeutics. Joining me on the call today from Halozyme are Jonathan Lim, President and Chief Executive Officer; Gregory Frost, Chief Scientific Officer, David Ramsay, Chief Financial Officer and Robert Little, Chief Commercial Officer.
This afternoon Halozyme released 2008 third quarter financial results. If you have not received this news release, or if you would like to be added to the company’s distribution list, please call Alex Schlam [ph] at 858-704-8288. This call is also being web cast live over the Internet at www.halozyme.com and a replay will be available on the company’s website for the next 30 days.
Before we begin, let me remind you that during this conference call we will be making forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides a Safe Harbor for forward-looking statements. All statements made during this conference call that are not statements of historical facts constitute forward-looking statements.
The matters referred to in forward-looking statements could be affected by the risks and uncertainties of Halozyme’s, business both known and unknown. Such risks inherent to company’s business are described in our filings with the Securities and Exchange Commission, as well as in our news releases. The company’s actual results may differ materially from those expressed and/or indicated by such forward-looking statements.
With that I’d like to now turn the call over to Jonathan Lim, President and CEO.
Thanks, Robert. Good afternoon, everyone. Thank you for joining us.
I’m pleased to report that Halozyme continues to make solid progress across the board with all of our product development initiatives. And that holds true for our three partnered programs and for our five proprietary pipelines products. With the current turmoil and dislocations in the financial markets, it is frustrating for us not to see our progress and hard work more fairly reflected in our share price.
Many of you on the call attended our analyst day presentation in New York on October 8, and I know that you as shareholders and investors who follow our company are experiencing the same frustration. However, we firmly believe that all of the activities we are pursuing to push our programs forward aggressively, both alone and with partners, are raising the intrinsic value of Halozyme significantly. Eventually, we expect that market conditions will improve and allow for evaluation of our company that more accurately reflects the value of our products, our development programs and our alliances.
Today I am going to provide a status report on our insulin program that includes both regular and analog formulations. Gregory Frost will discuss the status of our other proprietary programs such as PEG PH20. Bob Little will be updating you on our three partnered programs with Roche and Baxter, and David Ramsey will provide the highlights of our financial results.
As many of you know, HALO is focusing resources on the development of a proprietary pipeline that leverages our unique scientific understanding of the matrix which is the area between cells that contains structural proteins and various fibrous components. This area is a target rich environment for developing innovative therapeutic products. As part of this strategy, we have identified at least four multi billion dollar franchises which we are pursuing in parallel. These franchises represent opportunities in important therapeutic categories such as endocrinology, oncology, dermatology as well as drug delivery.
In each of these four years, we are developing innovative new drugs that are either best in class or first in class with very large sales potential. Any one of the franchises could result in lucrative partnerships for Halozyme and some could be products that we commercialize on our own because they are in specialty markets. The results of future clinical trials and the interest of potential partners we are in discussions with will be crucial in determining the specific opportunities that we pursue in partnership or on our own.
Five key internal programs comprise our current proprietary product development portfolio. The endocrinology franchise currently consists of insulin and bisphosphonates which apply our PH20 enzyme to currently approved and marketed products and transform them into value added proprietary products with unique patient benefits.
The oncology franchise consists of PEG PH20, a new molecular entity administered intravenously that targets the external environment which is rich in hyaluronin around tumor cells, and Chemophase which utilizes the PH20 enzyme for local administration in bladder cancer. Our lead enzyme in the dermatology franchise HTI-501. HTI-501 is a new molecular entity which digests collagen and may have applications in both medical and aesthetic dermatology such as cellulite.
So I am now going to provide you some specific details on our insulin program. We previously communicated that we would begin our Phase II insulin trial by the end of the year, and I am pleased to inform you that we have fulfilled this important objective. Just last week, Halozyme began dosing type I diabetic patients in a Phase II clinical trial that will test two commercially available insulin products, Humalog, and Humulin R regular insulin with and without our PH20 hyaluronidase enzyme.
We designed this phase II study to compare glycemic control of a standardized liquid meal challenge and insulin pharmacokinetics or PK after administration of each of four dosage regimens. Humulin R with and without PH20 and Humalog with and without PH20. The combination doses of insulin plus enzyme will be co-mixed and administered to the patients as a single injection. This crossover design single blind open label liquid meal study will collect data on at least 20 patients who complete the trial. Each study drug will be injected subcutaneously into the abdomen immediately prior to injection of the liquid meal.
Our Phase II insulin clinical program is based on extensive discussions with key opinion leaders in diabetes, outside consultants, potential partners, and among our own internal scientific and commercial teams to determine the trial design that will provide maximum information regarding this product. The primary end point, a PK measure, will be the area under the curve for plasma insulin concentration from zero to 60 minutes after injection. Secondary endpoints will include additional PK data as well as blood glucose concentration at various time points.
Safety data such as adverse reactions, hypoglycemia, blood chemistry and injection site tolerability will be collected, measured and evaluated. Patients may be on study for up to an estimated fourteen weeks from screening to completion and we look forward to presenting the results of this study at a medical or scientific forum in the middle of 2009.
As you may recall, the results of our Phase I trial yielded data for co-formulations of PH20 with regular and fast acting insulin that more closely mimicked physiologic mealtime insulin response compared to either insulin administered on its own. For example, the combo showed significantly faster absorption of each insulin that began within minutes after the injection. Based on this study, our enzyme boosted regular insulin in a way that makes it better than the current gold standard insulin analog. We are optimistic that we will be able to demonstrate similar results in the phase II program this time in patients that I described earlier.
The goal of all of our clinical programs would be to demonstrate meaningful advantages relative to existing treatments. So in the case of insulin enzyme combination compared to insulin alone, we’ll strive to demonstrate advantages such as reduced frequency of hypoglycemic events, better predictability of insulin treatment or reduced weight gain. We believe that with the clinical benefit in any one of these three parameters our combination insulin could become the best in class product, and potentially reduce the long term complications and associated costs of treating diabetic patients.
Demonstration of the unique clinical benefit would result in a differentiable insulin enzyme combination that would help to drive its acceptance by patients, physicians and third party payers. We also envision a commercial formulation would be a premixed, ready to use product for a pen or syringe application with no storage or reconstitution requirements that different from currently available insulin.
In terms of commercial opportunity, many refer to the rising incidence of diabetes as a worldwide epidemic and financial analysts estimate the growing Crandall [ph] insulin market at just over $3 billion in annual sales for the U.S. and Europe. So needless to say, this represents a substantial commercial opportunity. We are moving forward with development of subcutaneous formulation of our enzyme, with both the analog and regular insulin. Through the generation of additional clinical data during the next twelve months or so, we believe we can increase the value of the program for our shareholders and for potential partners.
I’ll now turn the call over to Greg Frost who will provide an update on our four other proprietary programs.
Thanks, Jonathan, and good afternoon, everyone.
I’ll be starting with an update on our two programs on oncology, intravenous PEG PH20 for solid tumors and Chemophase for superficial bladder cancer followed by a description of where we stand with other dermatology and bisphosphonates R&D efforts.
Recently we presented efficacy data at the AACR Translational Cancer meeting from animal tumors models with intravenous PEG PH20 in combination with either docetaxel or liposomal doxorubicin. Hyaluronin or HA is a dominant constituent of the tumor micro environment of many solid tumors and we believe it may increase resistance to chemotherapeutic agents.
The removal of HA from a tumor with our former PEG PH20 enzyme which consists of hyaluronidase enzyme with polyethylene glycol moieties attached results in a significant reduction in tumor size. HA removal also leads to significant reductions in tumor interstitial fluid pressure of IFP in tumors diffusion weighted MRI. Many experts believe that elevation tumor IFP may limit the response to cytotoxic treatment regimens in multiple solid tumors.
The data present at the July AACR meeting demonstrated a substantial increase in anti-tumor activity from the combination of a PEG PH20 with docetaxel and with doxarubicen. For example in the xenograft PC3 model, a tumor that produced pericellular HA, tumor volume growth over time was significantly reduced and survival significantly prolonged for the PEG PH20 plus docetaxel treatment group compared to the controlled or docetaxel groups alone.
In addition, effects on tumor mass were observed following treatment with the pegylated enzyme alone. This finding led us to conduct additional testing of PEG PH20 as monotherapy which has produced positive results. These new studies support our belief that the PEG PH20 program could lead to a potentially first in class montherapeutic and chemo adjuvant therapeutic by targeting HA in the tumor micro environment. A significant proportion of advanced cancers on the order of 20% to 90% including prostate, breast, ovarian, pancreatic and gastric carcinomas produce HA rich coatings which can prevent tumor cells from coming in contact with one another contribute to IFP and modifies some potentially important cellular signaling events.
Intravenously administered PEG PH20 can completely eradicate these types of sugar coatings, leading to a reduction in tumor volume and IFP within hours of intravenous administration. We are preparing to initiate studies during the first half of 2009 in cancer patients using PEG PH20. Our initial Phase I study will likely be a dose escalation trial of intravenously administered PEG PH20 in advanced cancer patients. End points will include pharmacokinetic, pharmacodynamic imaging and safety measures. We’ll also look for the maximum tolerated dose, dose limiting toxicities, and any signs of anti-tumor activity or resolution of pain. Results of this initial phase I trial will pave the way for phase one combination studies and subsequent phase II monotherapy trials. The results we have seen so far fuel our excitement for this program. And our preclinical toxicology and manufacturing efforts are continuing at full speed ahead.
Now shifting to our Chemophase program, Chemophase consists of combination of our PH20 enzyme plus mitomycin administered intravesically or in the bladder for the treatment of superficial bladder cancer. Recently we began patient enrollment and dosing in our immediate postoperative or IPOP or safety study which calls for Chemophase installation in the bladder immediately following transurethral resection of bladder batted tumors or TURBT. For this study, the primary end point is safety and tolerability of IPOP dosing with a secondary end point that assesses mitomycin plasma levels for three hours after dosing. An undetectable or negligible amount of mitomycin in plasma in the desired outcome. This study will be used to support inclusion of the IPOP dosing regiment as part of the protocol in future Chemophase registration studies.
Results of the IPOP trial should be available by the second quarter of 2009. In anticipation of success with this ongoing trial, we are planning for meetings with FDA and European regulators during the first half of 2009 in order to determine the optimal pathway to drug approval and the design of future Chemophase clinical registration studies.
Returning to dermatology, the lead candidate in our dermatology HTI-501 is a lysosomal proteinase that conditionally degrades collagen. We found that fibroseptae, the fiber like anchors in the skin that contribute to the dimpled appearance of cellulite are susceptible to this enzyme. HTI 501 which is the new chemical entity may be clinically useful in several medical as well aesthetic dermatology indications such as Dupuytren's contracture, scarring and cellulite.
Data that we presented for HTI-501 at two medical meetings earlier this year demonstrated that the enzyme can degrade collagen in vitro at the PH five to six but is completely inactive at physiology PH of 7.4. As a result of this PH controllability feature, HTI 501 may be advantageous relative to bacterial collagenase that tends to demonstrate persistent degradation of know surrounding tissue when administered.
We are conducting additional animal studies with HTI 501 to test a broad range of doses optimized for formulation and characterize the enzyme. Our scale up and process development work continues as we are producing investigational research batches now in house.
Now representing our second metabolism program is our bisphosphonates PH20 program, and this targets a multi billion dollar market that includes both oral and intravenous products. Oral products see alarmingly high patient discontinuation rates, sometimes 50% within twelve months of starting treatment due to compliance issues, gastrointestinal side effects and toxicity. IV bisphosphonate offers some advantages over the oral products in terms of tolerability that represent an inconvenience to patients and physicians. The subcutaneous administration of a bisphosphonates with PH20 could avoid side effects and compliance issues with the orals, and provide a more convenient route of administration relative to the IV products. So we remain on track to enter the clinic by the end of the year with a bisphosphonates PH20 combination formulation.
Now I’ll turn the call over to Bob Little who will give you an update on our partner programs.
Thank you, Greg. Halozyme has three distant partnership programs in place with two companies Roche and Baxter Bioscience for enhanced technology, as well as a partnership with Baxter Medication Delivery for Hylenex, our FDA approved drug.
I’ll start by discussing our enhanced partnership with Roche. Our Roche alliance continues to advance, and we are very pleased with the progress demonstrated to date. The Roche partnership has met or exceeded our expectations in every area. Manufacturing scale up of a higher yielding PH20 enzyme manufacturing process is making good progress and we expect that this enhanced production capacity will support Roche’s needs going forward, as well as well Halozyme’s internal programs. During the quarter, we entered into a clinical supply agreement with a second production source to produce additional manufacturing runs of clinical grade hyaluronidase during 2009.
Our second enhanced technology partnership is with Baxter Bioscience. Earlier this year, Baxter presented positive results from its Gammagard enhanced technology Phase I/II clinical trial that tested subcutaneous delivery of Gammagard following administration of our proprietary hyaluronidase enzyme. During its recent 2008 third quarter earnings conference call, Baxter announced that it submitted and IND to the FDA to conduct phase III clinical trials with Gammagard liquid plus Halozyme enhanced technology as a monthly subcutaneous injection for a single site for the treatment of primary immune deficiency. We are pleased with both the allocation of resources and the level of commitment demonstrated by Baxter Bioscience to push the Gammagard program very rapidly forward.
Now let me shift over to our Hylenex partnership. During the third quarter, Baxter Medication Delivery has continued to build out its sales and marketing infrastructure and has now hired and trained its first group of dedicated pediatric emergency department sales reps. These reps are in addition to those already on board who promote Hylenex to ambulatory surgery centers that perform ophthalmic surgery and are hospital based ophthalmologists. The initial focus of the pediatric sales force will be on obtaining formulary access at key emergency departments and treatment centers across the country. The pediatric hydration sales effort should jump into full swing during the second half of next year with the publication of the infused pediatric rehyrdation study. This recently completed clinical study provides solid evidence that subcutaneous fluid administration is a highly effective delivery alternative to the traditional IV approach for pediatric patients in the emergency room setting.
Our second pediatric hydration study that will involve approximately 150 patients will begin very shortly in leading pediatric and community hospitals that treat significant numbers of pediatric patients. Results of the study when available will further educate the physicians as to the effectiveness of Hylenex in the subcutaneous pediatric rehydration setting. Baxter’s top management continues to express a strong commitment to the sales of potential of Hylenex and is increasing investment in the commercial and clinical support of Hylenex.
Now finally our other enhanced technology partnership opportunities. Regarding our business development activity, we have multiple potential partners that are currently conducting feasibility studies to assess the use of our enzyme with their proprietary pharmaceutical and biologic compounds. Additional partnerships structured with the appropriate terms and with the right partner remain an important strategic objective for Halozyme.
And now I’ll turn the call over to David Ramsay. Thank you.
Thank you, Bob, and good afternoon, everyone. Our net loss for the third quarter of 2008 or $10.9 million or $0.14 per share compared with a net loss for the third quarter of 2007 of $7 million or $0.09 per share. For the nine months, our net loss totaled $31.8 million or $0.40 per share compared to $15.2 million or $0.21 per share during the first nine months of 2007. Revenues for the third quarter of 2008 were $2.5 million compared to $943,000 for the third quarter of 2007 and revenues under collaborative agreements for the third quarter of 2008 with $2.2 million compared with $758,000 for the third quarter of 2007. Revenues under collaborative agreements in 2008 primarily consisted of the amortization of upfront fees received from Baxter and Roche of $588,000 and research and development reimbursements from Baxter of $847,000 and Roche of $760,000.
Our research and development expenses for the third quarter of 2000 were $10.1 million compared with $6.4 million for the third quarter of 2007 reflecting increased compensation expenses, research and development spending on our PEG PH20, our insulin and dermatology both clinical and pre-clinical programs, and also the production cost associated with the manufacturing scale up of our PH20 enzyme.
As you heard Bob Little describe, this manufacturing scale up is important as it will provide Roche the API they need in order to meet their future requirements. Selling general and administration expenses for the third quarter of 2008 were $3.5 million compared with $2.8 million for the comparable period in 2007 reflecting increased compensation expense due to higher head count. Our financial position remains strong with cash and cash equivalents of $72.5 million as of September 30, 2008, compared with $97.7 million as of December 31, 2007. Our cash burn for the third quarter of 2008 was roughly $10 million.
That concludes my remarks and now I’ll return the call back over to Jonathan.
Thanks, David. At this point, I would like to summarize for you some of the goals and events that we expect to the occur within the next several quarters. The initiation of several phase I and phase II clinical trials in our insulin program, in addition to the Phase II that began in October, these additional studies will look at dose response over a range of insulin and enzyme doses or another would utilize three times per day meal time dosing of insulin plus enzyme over a one to two month period.
Initiation before the end of 2008 of a phase I clinical trial for PH20 bisphosphonates the only subcutaneous bisphosphonate for the treatment of osteoporosis, the initiation of a phase I clinical trial for PEG PH20 in solid tumors during the first half of 2009 and initiation of the phase III clinical trial in primary immunodeficiency by Baxter for Gammagard enhanced technology. So we have a lot of clinical trial activity going on, but also there’s potential announcements regarding progress of current partnerships as well as the signing of new partnerships may also happen. We look forward to future discussions with you regarding the exciting progress we’re making with our development and commercialization efforts in our various programs, especially the clinical progress of our proprietary pipeline.
So with that overview, let’s open it up for questions. Operator?
(Operator instructions). And your first question comes from the line of Kevin Jason [ph].
I guess that will be me, thanks a lot, guys.
Congratulations, nice quarter. Couple of things there, let’s talk about Baxter for a little bit here. Specifically I guess what are the plans here with Hylenex for the acute care market? Is that still priority for Baxter and kind of help us understand the roll out which continues to sort of work at is own pace, I suppose?
Yes, the roll out actually as I said is actually starting. In the hospital environment, it is important to bring first of all the key teaching centers on board in terms of formulary access, keeping in lead, advocacy of the technology, and that is currently happening. As I mentioned, the 50 patient pediatric study was recently completed, it’s being submitted as we speak for publication. And as soon as the manuscript is published and in the hands of the sales force, a fuller roll out will happen into the community hospitals, a much greater roll out during next year. So the first wave of sales people are trained, they are in the field today, and Baxter will continue to ramp up during 2009, with a significant launch as soon as the B21 [ph] study is published.
At the risk of getting ahead of ourselves, can you explain to us a little more clearly what the current selling effort behind Hylenex looks like by Baxter because it’s not showing up in your P&Ls? I think we are all expecting and hoping for a ramp here on the product, but I need is there – what are the sales people out in the field doing? I understand the value of published data to come, but I mean help us get a little bit more comfortable that there is a ramp up to come on this product, and help us understand where we are today?
Yes. Initially in most of these hospitals, we have to first of all get onto the formulary and that process has started both with a group of dedicated pediatric sales people as well as Baxter assigning their existing contract account teams across the country into major hospitals. And in the hospital environment, that can sometimes take three to six months to actually go to a P&T committee, get formulary access, provide the data, get funding before they actually start ordering. So, we are starting to see this process now ramping up, and will culminate as I said with the publication of the clinical data in the second half of next year, following which then there should be a full ramp up in the second half of 2009. That’s when we will start to really see some numbers appearing.
Fair enough. And are there still plans to target the acute care market in hospice et cetera in terms of patients with trouble with deep venous access is that less of a priority these days?
There are a number of other markets that are currently being considered; long term care being one, the nursing home market. Right now, the main focus is on the pediatric hydration market, just because this is seen as a significant opportunity. The study that we just completed, the data was very positive, and obviously I don’t want to go into too much of the detail since it hasn’t been accepted for publication yet, very highly accepted by both physicians as well as parents which is very important. So I think Baxter and we see that the pediatric hydration market being one where there is a very significant opportunity for children to be hydrated subcutaneously in emergency room setting. That is the main focus today.
Okay, fair enough. And just going over to the Gammagard partnership as well, the Hylenex and then perhaps I’ll get back in queue, are there any -- I mean how do we think about the opportunity for expansion into Alzheimer’s which I know is priority for Gammagard? I mean Baxter presumably will need a labeled indication for Alzheimer’s before you could do any proof of concept with the formulation, is that correct?
The Alzheimer’s programs are being driven by Baxter. At this point, we are focusing on the PID market with our enzyme, and that is the Phase III study that we are about to start very shortly. And so I’ll defer any Alzheimer’s comments for the future.
Okay. So there’s no plans currently for doing an Alzheimer’s study?
I can’t comment on that one way or the other.
Fair enough, thanks so much.
(Operator instructions). Your next question comes from the line of Lu Nan [ph].
Hi, guys. Lu Nan in for Yun [ph]. Just a question on the insulin program, in terms of potential partnership strategy, can you go over that and give us a little more color in terms of what type of study any potential partners wants to see before looking to a partnership?
Yes, so this is a very interesting program because we have the opportunity to combine the PH20 enzyme with both analog as well as regular insulin products. As we mentioned on previous calls, we already entered into discussions with various players in the insulin space, and there’s been widespread interest in this program. So we are initiating this phase II study with our eyes wide open in terms of knowing the kinds of endpoints that would be of interest to prospective partners. We also have a number of studies that will be enabling for own registration pathway with a regular insulin product, and so it gives us maximum flexibility in terms of being open to partnerships along the way but also driving forward with our own proprietary insulin program.
And just a quick question on the bisphosphonate program, for the Phase I (inaudible) are you looking to combine your technology with one product on the market or (inaudible) two, can you give us a little more color in terms what trends you are looking at (inaudible) can you give some more detail on that?
What I can say is that obviously we have been looking at the intravenous bisphosphonates that target on this. And obviously Boniva and zoledronate are the two key targets there. The actual design that we’re looking at actually is applicable to bisphosphonates as a class, but specifically what we’re looking at is a study that will address the tolerability of a desired dose of bisphosphonates based upon the volume by which it could be administered. So think of this where you start in a large volume with enzyme, we know this will be tolerated and safe, and then taking it down to see what target volume we can reach that is tolerated. And that will effectively then drive the process going out into pharmacokinetics studies and additional end points.
Next question, please?
(Operator instructions). And then there are no further questions at this time.
Halozyme has a unique and exciting business strategy with its five proprietary programs and three partnered programs that aim to leverage our core technology and knowledge base. We are not just developing one or two products, the strategy followed by many biotech companies. Instead HALO is leveraging its core technology and expertise across a number of therapeutic categories that represent large, established markets and substantial commercial opportunities.
Despite the breadth of our programs and the depth of our activities, we continue to operate in a capital efficient manner as demonstrated by our use of $25 million of cash during the first nine months of 2008. We believe this strategy will provide multiple opportunities for success that can drive significant value for our shareholders. We look forward to updating you again soon on our progress and will be presenting at the Lazard Conference on November 18 and at the Piper Jaffray Conference on December 3.
Again thank you for your support, for your interest in HALO and for your participation in today’s call. Take care, everyone.
That concludes today’s conference call. You may now disconnect.
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